Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula

Completed

• Conditions: Obstetric Fistula

• Registration Number: NCT01891149
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula.

Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula.

Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.

Detailed Description

This study is a cross-sectional study of 110 Malawian women who present for medical evaluation at the Fistula Care Centre in Lilongwe, Malawi. If a woman enrolls in the study, her demographic, medical history, physical exam, and lab data will be abstracted from her medical records at the Fistula Centre. She will also a pelvic ultrasound on each participant so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length, endometrial thickness and ovarian volume) can be evaluated. If the participant has an obstetric fistula, she will also complete an additional blood draw for lab testing. The laboratory tests will evaluate three hormones that are associated with amenorrhea and infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

1. Presentation to the Fistula Care Centre in Lilongwe for medical evaluation
2. Ability to consent for study participation in Chichewa
3. Female aged 18-45 years
4. Willingness to undergo pelvic ultrasound for assessment of pelvic organs

Exclusion Criteria

1. No history of pregnancy
2. History of hysterectomy
3. Current pregnancy or pregnancy within the past six weeks
4. Seriously or terminally ill

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cervical length	baseline

Secondary Outcome Measures

Name	Time	Method
Hormonal levels	baseline	FSH, Estradiol, AMH

Trial Locations

Locations (1)

Fistula Care Centre; 🇲🇼 Lilongwe, Malawi