Status:
COMPLETED
Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone
Lead Sponsor:
Gynuity Health Projects
Conditions:
Pregnancy Termination
Eligibility:
FEMALE
Phase:
NA
Brief Summary
A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will include a 200 mg ora...
Detailed Description
Non-surgical abortion methods have the potential to improve the quality and safety of women's reproductive health in the developing world. However, until recently, widespread availability and utilizat...
Eligibility Criteria
Inclusion
- Gestational age \< 63 days by LMP, ultrasound or clinical assessment.
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- Able to consent to study participation.
Exclusion
- Gestational age \> 63 days
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion including IUD in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00680394
Start Date
July 1 2007
End Date
May 1 2008
Last Update
March 13 2013
Active Locations (2)
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1
La Rabta Hospital
Tunis, Tunisia
2
Hung Vuong Hospital
Ho Chi Minh City, Vietnam