Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

NCT00466999 | Completed

• 1 other identifier: 2.2.2
• Study Type: interventional
• Target: 1,000
• Locations: 5 countries
• Sites: 6

Brief Summary

In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.

Conditions

Incomplete Abortion

Keywords

misoprostol; incomplete abortion; PAC

Outcome Measures

Primary Outcomes (1)

• Complete abortion without recourse to surgical intervention.

  follow up visit 7 days after initial treatment

Study Arms (2)

surgery

ACTIVE COMPARATOR

standard surgical treatment (either dilation and curettage or manual vacuum aspiration)

Procedure: surgery

misoprostol

ACTIVE COMPARATOR

400 mcg misoprostol

Drug: misoprostol

Interventions

misoprostol DRUG

single dose of 400 mcg misoprostol administered sublingually

misoprostol

surgery PROCEDURE

standard surgical treatment (dilation and curettage or manual vacuum aspiration)

surgery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Uterine size no larger than 12 weeks LMP at time of presentation for care.
• Past or present history of vaginal bleeding during pregnancy.
• Open cervical os.
• If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
• All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
• General good health.
• Willing to provide contact information for purposes of follow-up.
• Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).

You may not qualify if:

• Contraindications to study drug
• Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever \> 38 degrees C , 3) uterine tenderness
• Hemodynamic disturbances (pulse \>110/min and systolic bp \<100)
• Have an IUD in place; (the IUD may be removed making the woman eligible)
• Suspected ectopic pregnancy

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (6)

Dandé District Hospital/Ziniaré District Hospital

Dande/Ziniare, Burkina Faso

Location

El-Galaa Teaching Hospital

Cairo, Egypt

Location

Shatby Maternity Hospital/Alexandria University

Shatby, Alexandria, Egypt

Location

Cheikh Zayed Hospital

Nouakchott, Mauritania

Location

Maternite Issaka Gazobi

Niamey, Niger

Location

Centre de Sante Le Roi Baudouin

Guédiawaye, Senegal

Location

Related Publications (4)

• 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

• Shochet T, Diop A, Gaye A, Nayama M, Sall AB, Bukola F, Blandine T, Abiola OM, Dao B, Olayinka O, Winikoff B. Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries. BMC Pregnancy Childbirth. 2012 Nov 14;12:127. doi: 10.1186/1471-2393-12-127.

  PMID: 23150927 DERIVED

• Blandine T, Ouattara AZ, Coral A, Hassane C, Clotaire H, Dao B, Lankoande J, Diop A, Blum J. Sublingual [corrected] misoprostol as first-line care for incomplete abortion in Burkina Faso. Int J Gynaecol Obstet. 2012 Nov;119(2):166-9. doi: 10.1016/j.ijgo.2012.05.036. Epub 2012 Aug 28.

  PMID: 22935621 DERIVED

• Dabash R, Ramadan MC, Darwish E, Hassanein N, Blum J, Winikoff B. A randomized controlled trial of 400-mug sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals. Int J Gynaecol Obstet. 2010 Nov;111(2):131-5. doi: 10.1016/j.ijgo.2010.06.021.

  PMID: 20801444 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Abortion, Incomplete

Interventions

Misoprostol; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Rasha Dabash, MPH

  Gynuity Health Projects

  STUDY DIRECTOR

• Ayisha Diop, MPH

  Gynuity Health Projects

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

MA (1); BU (1); EG (2); NI (1); SE (1)