NCT03896243

Brief Summary

Investigators would like to see the amh values after uterine artery ligation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 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

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 27, 2019

Last Update Submit

March 28, 2019

Conditions

Keywords

Uterine atonyamh

Outcome Measures

Primary Outcomes (1)

  • 1.ovarian reserve in patients with uterine artery ligation

    calculation of ovarian reserve with amh (ng/ml) after uterine artery ligation due to uterine atony

    12 months

Study Arms (2)

Uterine artery ligation (UAL)

We would like toinvite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section. They would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Diagnostic Test: Uterine artery ligation (UAL)

Control Group:

We would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication. They would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Diagnostic Test: Uterine artery ligation (UAL)

Interventions

Uterine artery ligation (UAL) We will invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section. They will evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Control Group:Uterine artery ligation (UAL)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll participants are females undergoing delivery of their baby
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who had uterine artery ligation during C-section. Control group is age-matched postpartum patients.

You may qualify if:

  • age 18- 35 years
  • no systemic or endocrine diseases
  • patients who had uterine artery ligation due to atony
  • healthy postpartum patients as controls

You may not qualify if:

  • patients with PCOS
  • 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

Uterine Inertia

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

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

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 29, 2019

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
12 months

Locations