Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy
- Conditions
- Pregnancy Trimester, SecondMisoprostolCathetersAbortion, Second Trimester
- Interventions
- Device: Misoprostol/Transcervical catheter
- Registration Number
- NCT03106389
- Lead Sponsor
- Ain Shams Maternity Hospital
- Brief Summary
This randomized controlled study will be performed to compare the benefits and risks associated with the administration of misoprostol with or without the use of a transcervical balloon catheter to terminate pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation).
- Detailed Description
The study will be conducted at Ain Shams Maternity Hospital. An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive the standard misoprostol protocol for termination of second trimester pregnancy currently practiced at Ain Shams Maternity Hospital; 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours till complete expulsion of the uterine contents or surgical interference is decided. The second group will receive the exact same regimen, but will have in addition a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; and will have weighted traction applied to the catheter through using a 1000 ml fluid-filled bag in order to apply continuous pressure to the cervix. The target sample size was calculated to be 108 cases; randomization will be in a ratio of 1:1 using a computer-generated random sequence. Allocation will be concealed using sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will thus be randomly assigned to one of the groups.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 108
pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation) with a medical indication for termination of pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol/Transcervical catheter Misoprostol/Transcervical catheter This group will receive the same regimen, but will have in addition a transcervical balloon (Foleys') catheter that is inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix Misoprostol/Transcervical catheter Misoprostol This group will receive the same regimen, but will have in addition a transcervical balloon (Foleys') catheter that is inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix Misoprostol Misoprostol This group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours.
- Primary Outcome Measures
Name Time Method Induction-expulsion interval 48 hours from starting intervention The duration from the administration of the first misoprostol dose vaginally till complete expulsion of the uterine contents; complete uterine emptiness will be confirmed by ultrasonographic assessment
- Secondary Outcome Measures
Name Time Method Total required doses of misoprostol 48 hours from starting induction The total amount of misoprostol used per participant during the procedure
The need for surgical interventions 1 week from starting induction The number of participants requiring any surgical intervention under anesthesia to complete uterine emptiness
Trial Locations
- Locations (1)
Ain Shams University Maternity Hospital
🇪🇬Cairo Governorate, Cairo, Egypt