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

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ClinicalTrials.gov Identifier: NCT01891149
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : February 4, 2015
Sponsor:
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Jennifer Tang, MD, MSCR, 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.


Condition or disease
Obstetric Fistula

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 Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula
Study Start Date : December 2012
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Group/Cohort
Malawian women
Malawian women who present for care at the Fistula Care Centre



Primary Outcome Measures :
  1. Cervical length [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Hormonal levels [ Time Frame: baseline ]
    FSH, Estradiol, AMH



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We will be enrolling 100 Malawian women with obstetric fistula and 10 Malawian women without obstetric fistula.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891149


Locations
Malawi
Fistula Care Centre
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
American College of Obstetricians and Gynecologists
Investigators
Study Director: Jeffrey Wilkinson, MD University of North Carolina

Responsible Party: Jennifer Tang, MD, MSCR, Research Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01891149     History of Changes
Other Study ID Numbers: 12-1880
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical