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Second Trimester Labor Induction

A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00592215
Enrollment
0
Registered
2008-01-11
Start date
2008-03-31
Completion date
2010-10-31
Last updated
2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second Trimester Labor Induction

Keywords

Second trimester labor induction

Brief summary

A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions. The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.

Interventions

DRUGExperimental (mifepristone and misoprostol)

Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours

Sponsors

University of Maryland
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* English-speaking women * 18 years of age and above * Voluntarily choose to undergo pregnancy termination via labor induction * An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation * Able to provide written consent

Exclusion criteria

* Premature rupture of membranes * Preterm labor * Intrauterine fetal demise * Chronic systemic corticosteroid use or adrenal disease * Hypersensitivity to prostaglandins * Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure * Known coagulopathy or treatment with anticoagulants * Prior caesarean delivery or myomectomy * Placenta previa

Design outcomes

Primary

MeasureTime frame
Abortion rate8 hours after misoprostol administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026