Clinical trial NCT00466999: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Official title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Abortion
Keywords: misoprostol
incomplete abortion
PAC
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Complete abortion without recourse to surgical intervention.
timeFrame: follow up visit 7 days after initial treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Dande/Ziniare
country: Burkina Faso
facility: Dandé District Hospital/Ziniaré District Hospital
city: Cairo
country: Egypt
facility: El-Galaa Teaching Hospital
city: Shatby, Alexandria
country: Egypt
facility: Shatby Maternity Hospital/Alexandria University
city: Nouakchott
country: Mauritania
facility: Cheikh Zayed Hospital
city: Niamey
country: Niger
facility: Maternite Issaka Gazobi
city: Guediawaye
country: Senegal
facility: Centre de Sante Le Roi Baudouin
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Ayisha Diop, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.