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

Obstetric Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891149
• Other study ID #: 12-1880
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: February 3, 2015
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fistula
• Obstetric Fistula

Locations

Country	Name	City	State
Malawi	Fistula Care Centre	Lilongwe

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	American College of Obstetricians and Gynecologists

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical length		baseline	No
Secondary	Hormonal levels	FSH, Estradiol, AMH	baseline	No