Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula|
- Cervical length [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Hormonal levels [ Time Frame: baseline ] [ Designated as safety issue: No ]FSH, Estradiol, AMH
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Malawian women who present for care at the Fistula Care Centre
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891149
|Fistula Care Centre|
|Study Director:||Jeffrey Wilkinson, MD||University of North Carolina|