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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Jennifer Tang, MD, MSCR, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01891149
First received: June 25, 2013
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

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
Obstetric Fistula

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Cervical length [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hormonal levels [ Time Frame: baseline ] [ Designated as safety issue: No ]
    FSH, Estradiol, AMH


Estimated Enrollment: 110
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)
Groups/Cohorts
Malawian women
Malawian women who present for care at the Fistula Care Centre

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 25, 2013
Last Updated: August 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014