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

Misoprostol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03106389
• Other study ID #: OBINTVN1
• Status: Recruiting
• Phase: Phase 4
• First received: April 3, 2017
• Last updated: May 7, 2017
• Start date: March 1, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: May 2017
• Source: Ain Shams Maternity Hospital
• Contact: Alaa Elfeky, Professor
• Phone: +2001222157568
• Email: aelfeky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: July 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

Related Conditions & MeSH terms

• Abortion, Second Trimester
• Catheters
• Misoprostol
• Pregnancy Trimester, Second

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo Governorate	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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