Obstetric Fistula Clinical Trial
Official title:
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.
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. ;
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05444504 -
Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
|
N/A |