http://informahealthcare.com/jmf ISSN: 1476-7058 (print), 1476-4954 (electronic) J Matern Fetal Neonatal Med, 2015; 28(1): 93–96 ! 2015 Informa UK Ltd. DOI: 10.3109/14767058.2014.905909
ORIGINAL ARTICLE
Comparison of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by Yale Dermatologic Surgery on 05/15/15 For personal use only.
Mohamed Abd-Allah Rezk, Zakaria Sanad, Ragab Dawood, Mohamed Emarh, and Alaa Masood Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Menufia, Egypt
Abstract
Keywords
Objectives: To examine the effectiveness, safety and acceptability of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy. Methods: This clinical study was conducted on 90 pregnant patients intended for termination of pregnancy between 13 and 24 gestational weeks for any indication. Enrolled women are equally allocated into three groups: Group I (Misoprostol group): a standard regimen of moistened misoprostol (400 mg) 4 hourly inserted vaginally. Group II (Catheter group): intracervical Foley catheter inserted, inflated and placed on traction. Group III (Combined group): intracervical Foley catheter inserted with a standard regimen of moistened misoprostol (400 mg) 4 hourly intravaginally was used. Procedure efficacy (defined as complete abortion performed on site), safety and acceptability were assessed. Results: The induction to abortion interval was 7.5 ± 1.25 h in the combined group, compared to 11.76 ± 1.63 h in the misoprostol group and 19.76 ± 1.52 h in the catheter group (p value50.001) with a success rate of 100% and no major complications reported. Conclusions: The present results confirmed the high success rate with the shortest induction to abortion interval with a combined use of intracervical Foley catheter and misoprostol for termination of second trimester pregnancy.
Foley catheter, misoprostol, pregnancy termination, second trimester
Introduction Second trimester abortions constitute 10–15% of all induced abortions worldwide but are responsible for two-thirds of all major abortion-related complications [1]. For abortion at 13–24 weeks of gestation, medical abortion with mifepristone followed by a prostaglandin (PG) analogue is an appropriate method and has been shown to be safe and effective. The combination of mifepristone and misoprostol has synergistic effects and stimulates expulsion of the pregnancy [2–4]. In countries where mifepristone is not available or affordable, gemeprost or misoprostol alone have been shown to be effective, although a higher total dose is needed and is less effective than the combined regimens [5–7]. The induction-to-abortion interval, 10–15 h, is longer than with the combined treatment with mifepristone. Since a higher dose is required, the abortion process may have more side effects, such as nausea, vomiting, abdominal pain, fever Address for correspondence: Mohamed Abd-Allah Rezk, MD, Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, 25 Yasin Abd-elghafar street, Shibin Elkom, Menufia, Egypt. E-mail: [email protected]
History Received 25 December 2013 Revised 12 March 2014 Accepted 16 March 2014 Published online 9 April 2014
and shivering [8,9]. There is also a higher rate of failed abortion and continuing live pregnancy. With the misoprostol alone regimen, 80–90% of women will abort within 24 h [7]. Induction of abortion by the condom-Foley catheter method in pregnant women with intra-uterine fetal death at 20–28 weeks was reported within 24 h, with a 100% success rate when compared with oxytocin infusion alone [10]. The aim of this study was to compare the effectiveness, the safety and the acceptability of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy.
Materials and methods A prospective study including a total number of 90 patients was conducted in the Department of Obstetrics and Gynecology, Menoufia University Hospital between March 2012 and November 2013. The institutional review board approved the study protocol and an informed consent was obtained from all participants prior to commencing the study. The study was conducted on 90 healthy women admitted for termination of pregnancy between 13 and 24 weeks of
M. A.-A. Rezk et al. Enrollment
94
J Matern Fetal Neonatal Med, 2015; 28(1): 93–96
Assessed for eligibility (n=109) Excluded (n=19) -Not meeting inclusion criteria (n=11). -Declined to participate (n=8).
Allocation
Received intravaginal misoprostol (n=30)
Received intracervical catheter (n=30)
Received catheter & Misoprostol (n=30)
Follow up
-Lost follow up (n=0) -Discontinued intervention (n=0)
-Lost follow up (n=0) -Discontinued drug (n=0)
-Lost follow up (n=0) -Discontinued drug (n=0)
Analysis
J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by Yale Dermatologic Surgery on 05/15/15 For personal use only.
Randomized (n=90)
Analyzed (n=30)
Analyzed (n=30)
Analyzed (n=30)
Figure 1. Flow diagram.
pregnancy for any indication. We assumed that there will be a difference of 3 h between misoprostol group and other two groups concerning the induction to abortion interval from the literature. Accordingly, at alpha ¼ 0.05 and a study power of 80% a total sample size of 90 participants was required after adding a percentage of 10% for possible drop out cases during the study (Figure 1). A detailed history including age, parity and period of gestation were noted and details of clinical examination were also recorded. Ultrasonography was done to confirm gestational age, congenital malformation and placental localization. Patients with previous cesarean or any uterine scar, multiple pregnancies, severe anemia, hypertension, diabetes or with coagulopathy were excluded from the study. Enrolled women are equally allocated into three groups via restricted shuffled approach, through apportioning a number of 30 prepared cards for each treatment group according to the allocation ratio 1:1:1. The cards were inserted into opaque envelopes then were shuffled to produce a form of random assignment according to the final arrangement of the envelopes. There was no blinding of patients, as this is not feasible with these treatment methods: Group I (Misoprostol group): a standard regimen of moistened misoprostol (400 mg) 4 hourly intravaginally was used until abortion. Group II (Catheter group): intracervical Foley catheter inserted, inflated and placed on traction. Under aseptic conditions, with the patients lying in the lithotomy position, the cervix was assessed and Foley catheter No. 14-16 Fr Ch was inserted into the endocervical canal, beyond the internal os and the balloon was inflated with 50 ml of normal saline. The catheter was strapped to the thigh and kept in place until it was expelled spontaneously. Group III (Combined group): intracervical Foley catheter inserted with a standard regimen of moistened misoprostol (400 mg) 4 hourly intravaginally was used.
The primary outcome of the study was procedure efficacy, defined as complete abortion performed on site with no need for any surgical intervention. Secondary outcomes included safety and acceptability. Safety was assessed by comparing the prevalence of immediate major complications (death, thromboembolism or hemorrhage requiring blood transfusion) or minor complications (nausea, vomiting, diarrhea, fever, shivering, headache and cevico-vaginal lacerations). Acceptability included assessment of pain levels, emotional discomfort, likelihood of recommending the abortion method to other women and overall satisfaction rate. The cases were closely monitored for side effects, the onset of contraction, induction to abortion interval. Patients in whom effective uterine contractions and cervical dilatation was not obtained within 24 h with the primary termination method were registered as failures. All incomplete abortions were surgically evacuated, the decision to perform surgical evacuation was made on clinical basis, i.e. in cases of heavy bleeding or retained placenta. Routine sonographic evaluation was performed following abortion. All patients received prophylactic antibiotics, which included a combination of ampicillin and metronidazole for 5 days. Rh antibody was given to all the Rh negative cases at the end of the procedure. All patients were followed up for a period of 4 weeks. Statistical analysis Data were collected, tabulated, statistically analyzed by computer using SPSS version 16 (2006, SPSS Inc., Chicago, IL), two types of statistics were done: (1) Descriptive statistics: Quantitative data are expressed to measure the central tendency of data and diversion around the mean, mean (x) and standard deviation (SD). Qualitative data expressed in number and percentage. (2) Analytical statistics: ANOVA was used for comparison of more than two groups of normally distributed variables. The Kruskal–Wallis test was used for comparison of more than two groups of non-normally distributed variables; chi-square ( 2) tests were used to compare categorical outcomes. All these tests were used as tests of significance at p value 40.05 was considered statistically nonsignificant. p value 0.05 was considered statistically significant. p value 0.001 was considered statistically highly significant.
Results A total of 90 pregnant women were enrolled in this study. The socio-demographic data of these are presented in Table 1. There were no significant differences in age, gestational age and parity between patients. There is a high statistical difference between the three groups regarding the induction to abortion interval (IAI) with the shortest interval in the combined group (7.5 ± 1.25 h) compared to 11.76 ± 1.63 h in the misoprostol group and 19.76 ± 1.52 h in the catheter group.
Intravaginal misoprostol and intracervical Foley catheter
DOI: 10.3109/14767058.2014.905909
Table 2 shows the indications of pregnancy termination. Table 3 displays the minor maternal adverse effects with no difference between the three groups. Table 4 reveals the major maternal complications, there is partial failure of abortion in Table 1. Maternal characteristics and induction to abortion interval.
Group 1
Group 2
Group 3
Age 26.1 ± 4.6 26.3 ± 5.2 26.46 ± 5.01 Parity* 1.5 ± 1.11 1.8 ± 1.34 1.56 ± 1.38 Gestational 16.7 ± 2.99 17.43 ± 3.19 18.16 ± 3.14 age IAI 11.76 ± 1.63 19.76 ± 1.52 7.5 ± 1.25
ANOVA test p value 0.035 0.899 1.66
40.05 40.05 40.05
532.05 50.001
J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by Yale Dermatologic Surgery on 05/15/15 For personal use only.
*Kruskal–Wallis test. IAI: Induction to abortion interval. Table 2. Indications of termination of pregnancy. Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
Chi square
p value
20 7
18 11
19 9
1.99
40.05
3
1
2
IUFD Congenital anomalies PPROM
IUFD ¼ intrauterine fetal demise; PPROM ¼ preterm premature rupture of membranes. Table 3. Minor maternal adverse effects.
Nausea Vomiting Diarrhea Fever Shivering Headache
Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
Chi square
p value
5 9 10 11 8 10
3 5 4 7 4 5
6 11 9 10 7 11
1.2 3.1 3.6 1.3 1.7 3.4
40.05 40.05 40.05 40.05 40.05 40.05
Table 4. Major maternal complications.
Hemorrhage Partial failure Cervico-vaginal lacerations Blood transfusion VTE Death
Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
Chi square
p value
4 4 0
5 10 3
1 0 5
2.96 12.86 5.2
40.05 50.05 40.05
0 0 0
2 0 0
0 0 0
4.09 – –
40.05 – –
VTE ¼ Venous thrombo-embolism.
four cases in the misoprostol group and in 10 cases in the catheter group with the need for blood transfusion in two cases in the catheter group. Table 5 reveals the acceptability of different methods of pregnancy termination with no difference between the three groups.
Discussion Second trimester abortions are painful and stressful procedures. Various agents have been used and compared with misoprostol in second trimester pregnancy terminations [11–13]. Misoprostol is now widely used for second trimester terminations. However, there is still a need to find out the best route and dose with minimum IAI along with minimal side effects and complications [14]. Various adjuncts to misoprostol have been tried including oral mifepristone given 36–48 h prior to misoprostol which decreases the mean IAI [15], but increases the cost of treatment [16]. Vaginal misoprostol along with a laminaria tent has been tried [17] in which the rate of abortion 24 h after initiation of treatment was 69.7% in the 33 women receiving misoprostol alone and 68.6% in the 35 women treated with misoprostol and laminaria. In low resource settings, like our country, mifepristone is non-affordable and non-available as well as other prostaglandin preparations like prostaglandin E2 and PGF2-a. In order to shorten the induction to abortion interval and to minimize the side effects of misoprostol, we used intracervical Foley catheter alone and in conjunction with misoprostol inserted vaginally in a comparative fashion. The induction to abortion interval was 7.5 ± 1.25 h in the combined group, which is significantly shorter than using misoprostol alone or when combined with mifepristone 10– 15 h [8,9,14]. The rate of surgical evacuation in the present study was high in group (1) as 13% compared with the 3–9% described in earlier studies [18,19]. While in other studies, 8–11% of women needed surgical evacuation following medical abortion in the second trimester [20,21]. The success rate in our study was 100% in the combined group. There is only one randomized study which addressed the use of intracervical Foley catheter for termination of pregnancy between 14 and 28 weeks’ gestation and was published two decades ago [22] in which abortion within 48 h were achieved in 97.2% (71/73) of patients in the balloon group; in comparison to other four groups with the overall
Table 5. The acceptability of methods of termination of pregnancy.
Overall discomfort with abortion: – Moderate/High/Extreme – None or slight Overall satisfaction with abortion: – Very or somewhat satisfied – Neutral or somewhat not satisfied Would recommend the abortion method to other women: – Highly or somewhat agree – Neutral or somewhat disagree
95
Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
9 21
11 19
27 3 22 8
Chi square
p value
12 18
0.68
40.05
25 5
28 2
1.68
40.05
19 11
24 6
2.11
40.05
96
M. A.-A. Rezk et al.
median induction-abortion interval of 16.0 ± 15.4 h, but, no published studies addresses the use of both intracervical catheter and misoprostol for this purpose. In conclusion, second trimester termination of pregnancy in low resource settings using combination of intracervical Foley catheter and misoprostol is a safe, acceptable and cost effective method with a high success rate and short IAI.
J Matern Fetal Neonatal Med, 2015; 28(1): 93–96
10. 11.
12.
Declaration of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.
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References 1. Drey EA, Foster DG, Jackson RA, et al. Risk factors associated with presenting for abortion in the second trimester. Obstet Gynecol 2006;107:128–35. 2. Royal College of Obstetricians and Gynaecologists. The care of women requesting induced abortion. Guidelines No. 7. London; 2004. 3. Lalitkumar S, Bygdeman M, Gemzell-Danielsson K. Mid-trimester induced abortion: a review. Human Reprod Update 2007;13:37–52. 4. World Health Organization. Unsafe abortion: global estimates of the incidence of unsafe abortion and associated mortality in 2000. 4th ed. Geneva: WHO; 2004. 5. Ho PC, Ngai SW, Liu KL, et al. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Obstet Gynecol 1997;90:735–8. 6. Ngai SW, Tang OS, Ho PC. Randomized comparison of vaginal (200 microg every 3 h) and oral (400 microg every 3 h) misoprostol when combined with mifepristone in termination of second trimester pregnancy. Human Reprod 2000;15:2205–8. 7. Wong KS, Ngai CS, Yeo EL, et al. A comparison of two regimens of intravaginal misoprostol for termination of second trimester pregnancy: a randomized comparative trial. Human Reprod 2000; 15:709–12. 8. Herabutya Y, Chanrachakul B, Punyavachira P. Vaginal misoprostol in termination of second trimester pregnancy. J Obstet Gynaecol Res 2000;26:121–5. 9. Herabutya Y, Chanrachakul B, Punyavachira P. Second trimester pregnancy termination: a comparison of 600 and 800
13. 14. 15.
16. 17. 18. 19.
20. 21. 22.
micrograms of intravaginal misoprostol. J Obstet Gynaecol Res 2001;27:125–8. Mekbib TA. Induction of abortion by condom-Foley catheter method in pregnant women with intra-uterine foetal death. Ethiopian Med J 1994;32:107–13. Ghorab MN, El Helw BA. Second-trimester termination of pregnancy by extra-amniotic prostaglandin F2alfa or endocervical misoprostol. A comparative study. Acta Obstet Gynecol Scand 1998;77:429–32. Boza AV, de Leo´n RG, Castillo LS, et al. Misoprostol preferable to ethacridine lactate for abortions at 13–20 weeks of pregnancy: Cuban experience. Reprod Health Matters 2008;16:189–95. Herabutya Y, O-Prasertsawat P. Intra-cervical prostaglandin E2 gel in management of dead fetus in utero. Asia Oceania J Obstet Gynaecol 1991;17:335–9. Shipra K, Pradip KS, Poonam G, et al. Second trimester pregnancy termination with 400 mg vaginal misoprostol: efficacy and safety. BioSci Trends 2010;4:351–4. Rodger MW, Baird DT. Preteatment with mifepristone (RU486) reduces interval between prostaglandin administration and expulsion in second trimester abortion. Br J Obstet Gynaecol 1990;97: 41–5. Ho PC, Ma HK. Termination of second trimester pregnancy with sulprostone and mifepristone: a randomized double-blind placebocontrolled trial. Contraception 1993;47:123–9. Jain JK, Mishell Jr DR. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol 1996;175:173–7. Ashok PW, Templeton A, Wagaarachchi PT, Flett GM. Midtrimester medical termination of pregnancy: a review of 1002 consecutive cases. Contraception 2004;69:51–8. Hamoda H, Ashok PW, Flett GM, Templeton A. A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13–20 weeks gestation. Hum Reprod 2005;20:2348–54. Ashok PW, Templeton AA. Non surgical mid-trimester termination of pregnancy: a review of 500 consecutive cases. Br J Obstet Gynaecol 1999;106:706–10. Tang OS, Thong KJ, Baird DT. Second trimester medical abortion with mifepristone and gemeprost: a review of 956 cases. Contraception 2001;64:29–32. Yapar EG, Senoz S, Urkutur M, et al. Second trimester pregnancy termination including fetal death: comparison of five different methods. Eur J Obstet Gynecol Reprod Biol 1996;69:97–102.
ORIGINAL ARTICLE
Comparison of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by Yale Dermatologic Surgery on 05/15/15 For personal use only.
Mohamed Abd-Allah Rezk, Zakaria Sanad, Ragab Dawood, Mohamed Emarh, and Alaa Masood Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Menufia, Egypt
Abstract
Keywords
Objectives: To examine the effectiveness, safety and acceptability of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy. Methods: This clinical study was conducted on 90 pregnant patients intended for termination of pregnancy between 13 and 24 gestational weeks for any indication. Enrolled women are equally allocated into three groups: Group I (Misoprostol group): a standard regimen of moistened misoprostol (400 mg) 4 hourly inserted vaginally. Group II (Catheter group): intracervical Foley catheter inserted, inflated and placed on traction. Group III (Combined group): intracervical Foley catheter inserted with a standard regimen of moistened misoprostol (400 mg) 4 hourly intravaginally was used. Procedure efficacy (defined as complete abortion performed on site), safety and acceptability were assessed. Results: The induction to abortion interval was 7.5 ± 1.25 h in the combined group, compared to 11.76 ± 1.63 h in the misoprostol group and 19.76 ± 1.52 h in the catheter group (p value50.001) with a success rate of 100% and no major complications reported. Conclusions: The present results confirmed the high success rate with the shortest induction to abortion interval with a combined use of intracervical Foley catheter and misoprostol for termination of second trimester pregnancy.
Foley catheter, misoprostol, pregnancy termination, second trimester
Introduction Second trimester abortions constitute 10–15% of all induced abortions worldwide but are responsible for two-thirds of all major abortion-related complications [1]. For abortion at 13–24 weeks of gestation, medical abortion with mifepristone followed by a prostaglandin (PG) analogue is an appropriate method and has been shown to be safe and effective. The combination of mifepristone and misoprostol has synergistic effects and stimulates expulsion of the pregnancy [2–4]. In countries where mifepristone is not available or affordable, gemeprost or misoprostol alone have been shown to be effective, although a higher total dose is needed and is less effective than the combined regimens [5–7]. The induction-to-abortion interval, 10–15 h, is longer than with the combined treatment with mifepristone. Since a higher dose is required, the abortion process may have more side effects, such as nausea, vomiting, abdominal pain, fever Address for correspondence: Mohamed Abd-Allah Rezk, MD, Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, 25 Yasin Abd-elghafar street, Shibin Elkom, Menufia, Egypt. E-mail: [email protected]
History Received 25 December 2013 Revised 12 March 2014 Accepted 16 March 2014 Published online 9 April 2014
and shivering [8,9]. There is also a higher rate of failed abortion and continuing live pregnancy. With the misoprostol alone regimen, 80–90% of women will abort within 24 h [7]. Induction of abortion by the condom-Foley catheter method in pregnant women with intra-uterine fetal death at 20–28 weeks was reported within 24 h, with a 100% success rate when compared with oxytocin infusion alone [10]. The aim of this study was to compare the effectiveness, the safety and the acceptability of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy.
Materials and methods A prospective study including a total number of 90 patients was conducted in the Department of Obstetrics and Gynecology, Menoufia University Hospital between March 2012 and November 2013. The institutional review board approved the study protocol and an informed consent was obtained from all participants prior to commencing the study. The study was conducted on 90 healthy women admitted for termination of pregnancy between 13 and 24 weeks of
M. A.-A. Rezk et al. Enrollment
94
J Matern Fetal Neonatal Med, 2015; 28(1): 93–96
Assessed for eligibility (n=109) Excluded (n=19) -Not meeting inclusion criteria (n=11). -Declined to participate (n=8).
Allocation
Received intravaginal misoprostol (n=30)
Received intracervical catheter (n=30)
Received catheter & Misoprostol (n=30)
Follow up
-Lost follow up (n=0) -Discontinued intervention (n=0)
-Lost follow up (n=0) -Discontinued drug (n=0)
-Lost follow up (n=0) -Discontinued drug (n=0)
Analysis
J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by Yale Dermatologic Surgery on 05/15/15 For personal use only.
Randomized (n=90)
Analyzed (n=30)
Analyzed (n=30)
Analyzed (n=30)
Figure 1. Flow diagram.
pregnancy for any indication. We assumed that there will be a difference of 3 h between misoprostol group and other two groups concerning the induction to abortion interval from the literature. Accordingly, at alpha ¼ 0.05 and a study power of 80% a total sample size of 90 participants was required after adding a percentage of 10% for possible drop out cases during the study (Figure 1). A detailed history including age, parity and period of gestation were noted and details of clinical examination were also recorded. Ultrasonography was done to confirm gestational age, congenital malformation and placental localization. Patients with previous cesarean or any uterine scar, multiple pregnancies, severe anemia, hypertension, diabetes or with coagulopathy were excluded from the study. Enrolled women are equally allocated into three groups via restricted shuffled approach, through apportioning a number of 30 prepared cards for each treatment group according to the allocation ratio 1:1:1. The cards were inserted into opaque envelopes then were shuffled to produce a form of random assignment according to the final arrangement of the envelopes. There was no blinding of patients, as this is not feasible with these treatment methods: Group I (Misoprostol group): a standard regimen of moistened misoprostol (400 mg) 4 hourly intravaginally was used until abortion. Group II (Catheter group): intracervical Foley catheter inserted, inflated and placed on traction. Under aseptic conditions, with the patients lying in the lithotomy position, the cervix was assessed and Foley catheter No. 14-16 Fr Ch was inserted into the endocervical canal, beyond the internal os and the balloon was inflated with 50 ml of normal saline. The catheter was strapped to the thigh and kept in place until it was expelled spontaneously. Group III (Combined group): intracervical Foley catheter inserted with a standard regimen of moistened misoprostol (400 mg) 4 hourly intravaginally was used.
The primary outcome of the study was procedure efficacy, defined as complete abortion performed on site with no need for any surgical intervention. Secondary outcomes included safety and acceptability. Safety was assessed by comparing the prevalence of immediate major complications (death, thromboembolism or hemorrhage requiring blood transfusion) or minor complications (nausea, vomiting, diarrhea, fever, shivering, headache and cevico-vaginal lacerations). Acceptability included assessment of pain levels, emotional discomfort, likelihood of recommending the abortion method to other women and overall satisfaction rate. The cases were closely monitored for side effects, the onset of contraction, induction to abortion interval. Patients in whom effective uterine contractions and cervical dilatation was not obtained within 24 h with the primary termination method were registered as failures. All incomplete abortions were surgically evacuated, the decision to perform surgical evacuation was made on clinical basis, i.e. in cases of heavy bleeding or retained placenta. Routine sonographic evaluation was performed following abortion. All patients received prophylactic antibiotics, which included a combination of ampicillin and metronidazole for 5 days. Rh antibody was given to all the Rh negative cases at the end of the procedure. All patients were followed up for a period of 4 weeks. Statistical analysis Data were collected, tabulated, statistically analyzed by computer using SPSS version 16 (2006, SPSS Inc., Chicago, IL), two types of statistics were done: (1) Descriptive statistics: Quantitative data are expressed to measure the central tendency of data and diversion around the mean, mean (x) and standard deviation (SD). Qualitative data expressed in number and percentage. (2) Analytical statistics: ANOVA was used for comparison of more than two groups of normally distributed variables. The Kruskal–Wallis test was used for comparison of more than two groups of non-normally distributed variables; chi-square ( 2) tests were used to compare categorical outcomes. All these tests were used as tests of significance at p value 40.05 was considered statistically nonsignificant. p value 0.05 was considered statistically significant. p value 0.001 was considered statistically highly significant.
Results A total of 90 pregnant women were enrolled in this study. The socio-demographic data of these are presented in Table 1. There were no significant differences in age, gestational age and parity between patients. There is a high statistical difference between the three groups regarding the induction to abortion interval (IAI) with the shortest interval in the combined group (7.5 ± 1.25 h) compared to 11.76 ± 1.63 h in the misoprostol group and 19.76 ± 1.52 h in the catheter group.
Intravaginal misoprostol and intracervical Foley catheter
DOI: 10.3109/14767058.2014.905909
Table 2 shows the indications of pregnancy termination. Table 3 displays the minor maternal adverse effects with no difference between the three groups. Table 4 reveals the major maternal complications, there is partial failure of abortion in Table 1. Maternal characteristics and induction to abortion interval.
Group 1
Group 2
Group 3
Age 26.1 ± 4.6 26.3 ± 5.2 26.46 ± 5.01 Parity* 1.5 ± 1.11 1.8 ± 1.34 1.56 ± 1.38 Gestational 16.7 ± 2.99 17.43 ± 3.19 18.16 ± 3.14 age IAI 11.76 ± 1.63 19.76 ± 1.52 7.5 ± 1.25
ANOVA test p value 0.035 0.899 1.66
40.05 40.05 40.05
532.05 50.001
J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by Yale Dermatologic Surgery on 05/15/15 For personal use only.
*Kruskal–Wallis test. IAI: Induction to abortion interval. Table 2. Indications of termination of pregnancy. Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
Chi square
p value
20 7
18 11
19 9
1.99
40.05
3
1
2
IUFD Congenital anomalies PPROM
IUFD ¼ intrauterine fetal demise; PPROM ¼ preterm premature rupture of membranes. Table 3. Minor maternal adverse effects.
Nausea Vomiting Diarrhea Fever Shivering Headache
Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
Chi square
p value
5 9 10 11 8 10
3 5 4 7 4 5
6 11 9 10 7 11
1.2 3.1 3.6 1.3 1.7 3.4
40.05 40.05 40.05 40.05 40.05 40.05
Table 4. Major maternal complications.
Hemorrhage Partial failure Cervico-vaginal lacerations Blood transfusion VTE Death
Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
Chi square
p value
4 4 0
5 10 3
1 0 5
2.96 12.86 5.2
40.05 50.05 40.05
0 0 0
2 0 0
0 0 0
4.09 – –
40.05 – –
VTE ¼ Venous thrombo-embolism.
four cases in the misoprostol group and in 10 cases in the catheter group with the need for blood transfusion in two cases in the catheter group. Table 5 reveals the acceptability of different methods of pregnancy termination with no difference between the three groups.
Discussion Second trimester abortions are painful and stressful procedures. Various agents have been used and compared with misoprostol in second trimester pregnancy terminations [11–13]. Misoprostol is now widely used for second trimester terminations. However, there is still a need to find out the best route and dose with minimum IAI along with minimal side effects and complications [14]. Various adjuncts to misoprostol have been tried including oral mifepristone given 36–48 h prior to misoprostol which decreases the mean IAI [15], but increases the cost of treatment [16]. Vaginal misoprostol along with a laminaria tent has been tried [17] in which the rate of abortion 24 h after initiation of treatment was 69.7% in the 33 women receiving misoprostol alone and 68.6% in the 35 women treated with misoprostol and laminaria. In low resource settings, like our country, mifepristone is non-affordable and non-available as well as other prostaglandin preparations like prostaglandin E2 and PGF2-a. In order to shorten the induction to abortion interval and to minimize the side effects of misoprostol, we used intracervical Foley catheter alone and in conjunction with misoprostol inserted vaginally in a comparative fashion. The induction to abortion interval was 7.5 ± 1.25 h in the combined group, which is significantly shorter than using misoprostol alone or when combined with mifepristone 10– 15 h [8,9,14]. The rate of surgical evacuation in the present study was high in group (1) as 13% compared with the 3–9% described in earlier studies [18,19]. While in other studies, 8–11% of women needed surgical evacuation following medical abortion in the second trimester [20,21]. The success rate in our study was 100% in the combined group. There is only one randomized study which addressed the use of intracervical Foley catheter for termination of pregnancy between 14 and 28 weeks’ gestation and was published two decades ago [22] in which abortion within 48 h were achieved in 97.2% (71/73) of patients in the balloon group; in comparison to other four groups with the overall
Table 5. The acceptability of methods of termination of pregnancy.
Overall discomfort with abortion: – Moderate/High/Extreme – None or slight Overall satisfaction with abortion: – Very or somewhat satisfied – Neutral or somewhat not satisfied Would recommend the abortion method to other women: – Highly or somewhat agree – Neutral or somewhat disagree
95
Group 1 N ¼ 30
Group 2 N ¼ 30
Group 3 N ¼ 30
9 21
11 19
27 3 22 8
Chi square
p value
12 18
0.68
40.05
25 5
28 2
1.68
40.05
19 11
24 6
2.11
40.05
96
M. A.-A. Rezk et al.
median induction-abortion interval of 16.0 ± 15.4 h, but, no published studies addresses the use of both intracervical catheter and misoprostol for this purpose. In conclusion, second trimester termination of pregnancy in low resource settings using combination of intracervical Foley catheter and misoprostol is a safe, acceptable and cost effective method with a high success rate and short IAI.
J Matern Fetal Neonatal Med, 2015; 28(1): 93–96
10. 11.
12.
Declaration of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.
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