NCT02669420

Brief Summary

The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

January 23, 2016

Last Update Submit

January 27, 2016

Conditions

Intra Uterine Fetal Death

Outcome Measures

Primary Outcomes (1)

  • mean duration from the initial misoprostol dose until complete fetal expulsion

    24 hours

Study Arms (2)

extra amniotic misoprostol

EXPERIMENTAL

misoprostol dissolved in warm saline , become dissolute misoprostol saline solution(200 microgram every 4 hours)

Procedure: termination of second trimester pregnancy

vaginal misoprostol

EXPERIMENTAL

misoprostol tablet soaked with distilled water and inserted in the posterior fornix of the vagina( 200 microgram every 4 hours)

Procedure: termination of second trimester pregnancy

Interventions

termination of second trimester pregnancyPROCEDURE

Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial

extra amniotic misoprostolvaginal misoprostol

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy 13-24 weeks.
  • Women with indication for termination of the pregnancy due to intra uterine fetal death

You may not qualify if:

  • Pregnancy beyond 24 weeks.
  • Women with scared uterus.
  • Known hypersensitivity for misoprostol.
  • Refusal of the woman to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.

    PMID: 34061352DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 23, 2016

First Posted

February 1, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 1, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share