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

NCT03106389 | Unknown Phase 4 DMC

• 1 other identifier: OBINTVN1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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).

Conditions

Pregnancy Trimester, Second; Misoprostol; Catheters; Abortion, Second Trimester

Keywords

misoprostol; transcervical balloon catheter; second trimester; induced abortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total required doses of misoprostol

  48 hours from starting induction

• The need for surgical interventions

  1 week from starting induction

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

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

Misoprostol/Transcervical catheter

EXPERIMENTAL

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; Device: Misoprostol/Transcervical catheter

Interventions

Misoprostol DRUG

400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion

Also known as: Cytotec, Misotac

Misoprostol; Misoprostol/Transcervical catheter

Misoprostol/Transcervical catheter DEVICE

Foleys' catheter introduced into the cervix and inflated with 30 ml. of fluid; weighted traction applied by using a 1000 ml fluid-filled bag

Also known as: Foley catheter

Misoprostol/Transcervical catheter

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo Governorate, Cairo Governorate, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Alaa Elfeky, Professor

  AinShams University Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Elfeky, Professor

CONTACT

+2001222157568; aelfeky@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of ObGyn, Ain Shams University

Model Details: 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 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours. The second group will receive the same regimen, but in addition will have a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix. The target sample size is 108 cases randomized in a ratio of 1:1 using a computer-generated random sequence, allocation will be concealed in sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will be randomly assigned to one of the two groups.

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 10, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: July 31, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)