NCT03106389

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Misoprostol	400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion
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

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-06-30
• Completion: 2017-07-31
• First posted: 2017-04-10
• Last updated: 2017-05-09

Locations

1 site across 1 country: Egypt