A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death

NCT00141895 | Terminated Phase 3

• 1 other identifier: OGY.AN.03
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements. Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.

Conditions

Labor Induction

Keywords

Intrauterine fetal death, 2nd trimester, induction

Outcome Measures

Primary Outcomes (1)

• -The main outcome measures will be the induction time, defined as the time from placement of the first dose of misoprostol until the time of delivery of the fetus.

  48 hours

Secondary Outcomes (6)

• The entry characteristics of the patients, including age, height, weight, parity, gestational age at induction, indication for the induction, and cervical score before the start of the induction

  48 hours

• The delivery rate within 24 hours of prostaglandin commencement

  48 hours

• Number of doses of misoprostol given

  48 hours

• Number of unsuccessful inductions

  48 hours

• Length of hospital stay

  48 hours

Study Arms (2)

A

ACTIVE COMPARATOR

Vaginal Cytotec at doses of 400 microgram every 4 hours until delivery

Drug: Misoprostol

B

ACTIVE COMPARATOR

Sublingual Cytotec at doses of 400 microgram every 4 hours until delivery

Drug: Misoprostol

Interventions

Misoprostol DRUG

2 tablets 200 micrograms Vaginal route

Also known as: Cytotec

A

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• and 24 weeks of gestation
• Both nulliparous and multiparous women
• An unfavorable cervix (Bishop's score less than 8)

You may not qualify if:

• Known contraindications to the use of prostaglandins (e.g. asthma)
• Previous uterine scar (previous cesarean or myomectomy where the endometrial cavity was entered)

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

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: 34061352 DERIVED

MeSH Terms

Conditions

Stillbirth

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; 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

• Anwar H Nassar, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

LE (1)