Clinical trial NCT00670761: Misoprostol for the Treatment of Incomplete Abortion
Official title: Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Incomplete
Keywords: misoprostol
incomplete abortion
sublingual
postabortion care
MVA
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Befelatanana Maternity Centre
name: Municipal Clinical Hospital No. 1
name: Kagera Regional Hospital
name: Jose Macamo Hospital
name: Tudu hospital
name: National OBGYN hospital
name: Cuchi General District hospital
name: Hôpital de District Sanitaire Dandé
name: Hôpital de District Sanitaire de Ziniaré
First posted: 2008-05-02
Enrollment: 720
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.

Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:

In Tanzania and Mozambique:

1. 600 mcg of oral misoprostol in one dose, or
2. Standard surgical treatment (MVA)

In Moldova and Madagascar:

1. 600 mcg of oral misoprostol in one dose, or
2. 400 mcg of sublingual misoprostol in one dose.

In Burkina Faso and Vietnam:

1. 400 mcg of sublingual misoprostol in one dose.

We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.


Eligibility criteria: Inclusion Criteria:

* If no ultrasound used:

  1. Past or present history of vaginal bleeding during pregnancy; and
  2. Open cervical os.
* If ultrasound used:

  1. Past or present history of vaginal bleeding during pregnancy; and
  2. 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.

* Willing to provide contact information for purposes of follow-up.

  * In Tanzania: 18 years of age or over or parental permission
  * In Mozambique: 21 years of age or over or parental permission
  * In Moldova: 18 years of age or over
  * In Madagascar: 18 years of age or parental permission
  * In Vietnam: reproductive age

Exclusion Criteria:

* Contraindications to the study drug;
* Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
* Signs of severe infection, defined as at least one of the following of:

  1. foul smelling discharge,
  2. fever \> 39 degrees C ,
  3. pulse \>110/min;

Primary outcomes:
measure: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason
timeFrame: one week after initial treatment with the option of an additional week
Secondary outcomes:
Other outcomes:
Locations:
city: Bobo Dioulasso
country: Burkina Faso
facility: Hôpital de District Sanitaire Dandé
city: Ouagadougou
country: Burkina Faso
facility: Hôpital de District Sanitaire de Ziniaré
city: Antananarivo
country: Madagascar
facility: Befelatanana Maternity Centre
city: Chishinau
country: Moldova, Republic of
facility: Municipal Clinical Hospital
city: Maputo
country: Mozambique
facility: Jose Macamo Hospital
city: Bukoba
country: Tanzania
facility: Kagera Regional Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngoc NT, Shochet T, Blum J, Hai PT, Dung DL, Nhan TT, Winikoff B. Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting. BMC Pregnancy Childbirth. 2013 May 22;13:118. doi: 10.1186/1471-2393-13-118.