NCT03907605

Brief Summary

Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. There are many studies about AMH changes in ovarian surgery, but little is known for other surgeries. We seek to investigate the hormone variations before and after uterine artey ligation for postpartum hemorrage (PPH)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 6, 2019

Last Update Submit

April 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1- Anti-Mullerian Hormone levels variation

    Anti-Mullerian Hormone levels before and 3 months after surgery

    3 months

Interventions

All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who need artery ligation for PPH during C-section.

You may qualify if:

  • age 18- 40 years
  • no systemic or endocrine diseases
  • patients who had uterine artery ligation due to PPH

You may not qualify if:

  • Pregnancy with IVF or oosit donation
  • Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc.
  • Patients with BMI \>40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Anti-Mullerian Hormone

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Testicular HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 9, 2019

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Locations