Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

• ClinicalTrials.gov Identifier: NCT00969982
• Recruitment Status: Completed
• First Posted: September 2, 2009
• Last Update Posted: February 20, 2014
• Sponsor: Gynuity Health Projects
• Information provided by (Responsible Party): Gynuity Health Projects

Study Description

Brief Summary:

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Condition or disease	Intervention/treatment	Phase
Abortion, Induced	Drug: mifepristone+misoprostol; Drug: misoprostol+placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial
• Study Start Date: June 2009
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: mifepristone+misoprostol; 200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).	Drug: mifepristone+misoprostol; single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
Active Comparator: misoprostol; Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).	Drug: misoprostol+placebo; placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.

Outcome Measures

Primary Outcome Measures :

1. Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. [ Time Frame: 48 hours ]
2. Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. Provision of additional interventions to manage excessive blood loss [ Time Frame: from start of treatment until discharge ]
2. Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: start of treatment until discharge ]
3. Total dose of misoprostol. [ Time Frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given. ]
4. Pain experienced by the woman as self-reported. [ Time Frame: Assessed during exit interview. ]
5. Women's acceptability of the assigned method [ Time Frame: Assessed at exit interview ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
• Meet legal criteria to obtain abortion
• Present with closed cervical os and no vaginal bleeding
• Live fetus at time of presentation for service
• Have no contraindications to study procedures, according to provider
• Be able to consent to procedure, either by reading consent document or by having consent document read to her
• Be willing to follow study procedures

Exclusion Criteria:

• Known previous transmural uterine incision
• Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
• Any contraindications to vaginal delivery, including placenta previa
• Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Contacts and Locations

Locations

Moldova, Republic of

Municipal Clinical Hospital

Chishinau, Moldova, Republic of

Tunisia

La Rabta Maternity Hospital

Tunis, Tunisia

Sponsors and Collaborators

Gynuity Health Projects

Investigators

• Principal Investigator: Beverly Winikoff; Gynuity Health Projects

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dabash R, Chelli H, Hajri S, Shochet T, Raghavan S, Winikoff B. A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy. Int J Gynaecol Obstet. 2015 Jul;130(1):40-4. doi: 10.1016/j.ijgo.2015.02.023. Epub 2015 Apr 11.

• Responsible Party: Gynuity Health Projects
• ClinicalTrials.gov Identifier: NCT00969982
• Other Study ID Numbers: 1.4.1
• First Posted: September 2, 2009
• Last Update Posted: February 20, 2014
• Last Verified: February 2014

Keywords provided by Gynuity Health Projects:

Pregnancy termination; abortion; medical abortion; 2nd trimester; mifepristone; misoprostol

Additional relevant MeSH terms:

Misoprostol; Mifepristone; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Anti-Ulcer Agents; Gastrointestinal Agents; Oxytocics; Abortifacient Agents, Steroidal; Contraceptives, Oral, Synthetic; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Luteolytic Agents; Menstruation-Inducing Agents