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

NCT ID: NCT03106389

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

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

Misoprostol/Transcervical catheter

Intervention Type: 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

Interventions

Misoprostol

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

Intervention Type: DRUG

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

Intervention Type: DEVICE

Other Intervention Names

Cytotec; Misotac; Foley catheter

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alaa Elfeky

Professor of ObGyn, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa Elfeky, Professor

Role: PRINCIPAL_INVESTIGATOR

AinShams University Maternity Hospital

Locations

Ain Shams University Maternity Hospital

Cairo Governorate, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Alaa Elfeky, Professor

Role: CONTACT

aelfeky@gmail.com

+2001222157568

Facility Contacts

Alaa Elfeky, Professor

Role: primary

aelfeky@gmail.com

+201222157568

Other Identifiers

OBINTVN1

Identifier Type: -

Identifier Source: org_study_id