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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01539408
Other study ID # 2.2.3
Secondary ID
Status Completed
Phase Phase 1
First received February 16, 2012
Last updated February 21, 2012
Start date August 2009
Est. completion date October 2010

Study information

Verified date February 2012
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority Nigeria: Ministry of Health
Study type Interventional

Clinical Trial Summary

Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- no contraindications to misoprostol

- uterine size was not larger than 12 weeks

- there were no signs of severe infection

- haemodynamically stable

- in general good health

- willing to provide contact information

Exclusion Criteria:

- an IUD in place

- ectopic pregnancy

- aged below 18 years and had no accompanying adult to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Misoprostol
single dose of 400 mcg misoprostol administered sublingually
Procedure:
surgery Manual vacuum aspiration (MVA)
standard surgical treatment

Locations

Country Name City State
Nigeria Adeoyo Maternity Hospital Ibadan
Nigeria University College Hospital, Ibadan Ibadan

Sponsors (1)

Lead Sponsor Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete abortion without recourse to surgical intervention follow up visit 7 days after initial treatment No
See also
  Status Clinical Trial Phase
Completed NCT01939457 - 400mcg Sublingual Misoprostol as First Line Treatment N/A
Recruiting NCT05342467 - Gemeprost Versus Dinoprostone in First Trimester Miscarriages Phase 2
Completed NCT00674232 - Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment N/A
Completed NCT02707653 - Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research N/A
Not yet recruiting NCT05343546 - Ideal Timing of Intrauterine Contraception Insertion After Medical Management of First Trimester Incomplete Abortion N/A
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A
Completed NCT00466999 - Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion N/A
Completed NCT03622073 - Misoprostol Treatment of Mid Trimester Incomplete Abortion by Midwives and Doctors in Uganda. N/A
Completed NCT01743508 - Misoprostol Treatment of Incomplete Abortion by Midwives and Physicians in Uganda N/A