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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Labor Induction	Drug: Misoprostol	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Intrauterine Fetal Death
Study Start Date :	September 2004
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: A; Vaginal Cytotec at doses of 400 microgram every 4 hours until delivery	Drug: Misoprostol; 2 tablets 200 micrograms Vaginal route; Other Name: Cytotec
Active Comparator: B; Sublingual Cytotec at doses of 400 microgram every 4 hours until delivery	Drug: Misoprostol; 2 tablets of 200 micrograms Sublingual route; Other Name: Cytotec

Outcome Measures

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Primary Outcome Measures :

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. [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. 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 [ Time Frame: 48 hours ]
2. The delivery rate within 24 hours of prostaglandin commencement [ Time Frame: 48 hours ]
3. Number of doses of misoprostol given [ Time Frame: 48 hours ]
4. Number of unsuccessful inductions [ Time Frame: 48 hours ]
5. Length of hospital stay [ Time Frame: 48 hours ]
6. Need for surgical intervention to remove the placenta [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Lebanon
American University of Beirut Medical Center
Beirut, Lebanon

Sponsors and Collaborators

American University of Beirut Medical Center

Investigators

Principal Investigator:	Anwar H Nassar, MD	American University of Beirut Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Anwar Nassar, professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:	NCT00141895 History of Changes
Other Study ID Numbers:	OGY.AN.03
First Posted:	September 2, 2005
Last Update Posted:	July 19, 2013
Last Verified:	July 2013

Keywords provided by Anwar Nassar, American University of Beirut Medical Center:

Intrauterine fetal death, 2nd trimester, induction

Additional relevant MeSH terms:

Fetal Death; Stillbirth; Pregnancy Complications; Death; Pathologic Processes; Misoprostol; Abortifacient Agents, Nonsteroidal	Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Anti-Ulcer Agents; Gastrointestinal Agents; Oxytocics