Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy

Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy: A Randomized Controlled Trial

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).

Study Overview

• Status: Unknown
• Conditions: Abortion, Second Trimester; Misoprostol; Pregnancy Trimester, Second; Catheters
• Intervention / Treatment: Drug: Misoprostol; Device: Misoprostol/Transcervical catheter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alaa Elfeky, Professor; Phone Number: +2001222157568; Email: aelfeky@gmail.com

Study Locations

• Egypt
  • Cairo
    • Cairo Governorate, Cairo, Egypt, 11591
      • Recruiting
      • Ain shams university maternity hospital
      • Contact: Alaa Elfeky, Professor; Phone Number: +201222157568; Email: aelfeky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation) with a medical indication for termination of pregnancy.

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Exclusion Criteria:

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Misoprostol; 400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion; Other Names: Cytotec; Misotac
Experimental: 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	Drug: Misoprostol; 400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion; Other Names: Cytotec; Misotac; Device: Misoprostol/Transcervical catheter; Foleys' catheter introduced into the cervix and inflated with 30 ml. of fluid; weighted traction applied by using a 1000 ml fluid-filled bag; Other Names: Foley catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction-expulsion interval	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	48 hours from starting intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total required doses of misoprostol	The total amount of misoprostol used per participant during the procedure	48 hours from starting induction
The need for surgical interventions	The number of participants requiring any surgical intervention under anesthesia to complete uterine emptiness	1 week from starting induction

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Principal Investigator: Alaa Elfeky, Professor, AinShams university maternity hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): June 30, 2017
• Study Completion (Anticipated): July 31, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 7, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: misoprostol; second trimester; induced abortion; transcervical balloon catheter
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: OBINTVN1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available after publication of the study upon formal request by researchers and research centers that collaborate with Ain Shams Maternity Hospital. Data could be obtained through contacting PI by email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No