Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections

Study Overview
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Brief Summary
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it is a randomized controlled trial comparing the safety and efficacy of Vaginal Misoprostol versus combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester Pregnancy Termination. the patients will be sorted into 2 groups, Group I (Misoprostol group): seventy-nine patients and Group II (Combined group): seventy- nine patients. safety and efficacy of the procedure will be followed up and documented.

Detailed Description
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Design: prospective randomized controlled trial Sitting: department of Obstetrics and Gynecology Faculty of Medicine, Zagazig University, Zagazig, Egypt Sample size calculation: thoroughly reviewing the use of vaginal misoprostol and intracervical Foleys catheter alone or in combination for mid trimester pregnancy termination, Rezk et al 2014 showed that the percentage of complications fever and diarrhea in the first group (misoprostol) was 30 % versus complications in the second group (intra cervical Foleys group) cervical laceration was 13.3 %. Therefore, at confidence level 95% and power 80%, using Epi info 7 the Sample size will be one hundred fifty-eight (158) patients. Study participants: the study will include women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of gestation. The investigators will involve patients with a singleton pregnancy with one or multiple cesarean delivery. The investigators will exclude all patients with critical co-morbidities: bleeding disorders, chorioamnionitis, low-lying placenta, rupture uterus, myomectomy and contraindication to misoprostol or latex allergy. All women will undergo history taking, general examination, and local assessment for the cervix. Departmental US to confirm the diagnosis and indication for termination and position of the placenta. Blood tests will be done including blood group, full blood count matching, Antibodies screening and viral markers. Randomization: After meeting eligibility criteria all participants will be counseled to the clinical trial. A signed documented consent form will be attached to their medical records. The patients will be sorted into two groups using a computerized random number generator in a sequence of sealed, numbered opaque envelopes, with a 1:1randomization ratio. Group I (Misoprostol group): seventy-nine patients will receive a loading dose of moistened misoprostol tablets (cytotec pfizer 400 mg) inserted vaginally and it will be followed by maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of effective uterine contraction with maximum five doses in 24 hours duration . Group II (Combined group): seventy- nine patients will get intracervical Foleys Catheter insertion .Exposure of the cervix by means of a sterile speculum, a 16F Foley catheter will be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed through inflation of the balloon with 30 milliliters of sterile solution when the catheter will be beyond the internal cervical os. Slight traction of the catheter will be exerted through tapping it to the inner thigh. After six hours of Foleys catheter fixation, The investigators will start infusion of 10 IU of oxytocin on 500 ml ringer lactate by rate 125 ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by 5IU each time until achieving regular uterine contraction, maximum five doses in twenty -four hours duration. Therefore the maximum dose of oxytocin 100 IU over 24 hrs duration to avoid water intoxication. Failed induction of abortion is considered if no fetal expulsion occurred within twenty for hours from the use of primary method of termination. The Demographic data and serial clinical monitoring will be recorded by the assigned on duty registrar.

Official Title
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Vaginal Misoprostol Versus Combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections

Conditions
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Second Trimester Abortion

Intervention / Treatment
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* Procedure: compare misoprostol with combined oxytocin and cervical foly catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of gestation singleton pregnancy one or multiple cesarean delivery. Exclusion Criteria: bleeding disorders chorioamnionitis low-lying placenta history of rupture uterus history of myomectomy contraindication to misoprostol latex allergy.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (Misoprostol group):<br>seventy-nine patients will receive a loading dose of moistened misoprostol tablets ( Cytotec pfizer 400 mg) inserted vaginally and it will be followed by maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of effective uterine contraction with maximum five doses in 24 hours duration . | Procedure: compare misoprostol with combined oxytocin and cervical foly catheter<br>* we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group<br>|
| Active Comparator: Group II (Combined group):<br>seventy- nine patients will get intracervical Foleys Catheter insertion .a 16F (french units) Foley catheter will be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed through inflation of the balloon with 30 milliliters of sterile solution when the catheter will be beyond the internal cervical os. After six hours of Foleys catheter fixation, we will start infusion of 10 international units (IU) of oxytocin on 500 ml ringer lactate by rate 125 ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by 5 IU each time until achieving regular uterine contraction, maximum five doses in twenty -four hours duration. | Procedure: compare misoprostol with combined oxytocin and cervical foly catheter<br>* we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to cervical dilatation in hours | time between starting the medications and the real cervical dilatation | 24 hours | 
| induction abortion interval in hours | time between induction of abortion and expulsion of the products of conception | 48 hours | 
| need for surgical evacuation | some cases may be presented with retained products of conception with the need for surgical evacuation of the uterus | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sever hemorrhage | comparing the prevalence of severe hemorrhage by postoperative hemoglobin percent in both groups. | 48 hours | 
| patients satisfaction | by patient written questionnaire about patient discomfort. | 72 hours | 
| post-abortive infection | Number of participants with post-abortive infection is predicted by post-abortive C reactive protein (CRP) level | 7 days | 
| rupture uterus | comparing the incidence of rupture uterus (clinically by sever abdominal pain and loss of uterine contractions and presence of free fluid by ultrasound) in both groups | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abortion