NCT03220594

Brief Summary

To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

July 14, 2017

Last Update Submit

September 29, 2017

Conditions

Keywords

hypogastric arteryanti-mullerian hormoneovarian reservepostpartum

Outcome Measures

Primary Outcomes (1)

  • Ovarian reserve

    To evaluate postoperative ovarian reserve using anti-mullerian hormones and other ovary related hormones including FSH,LH

    6 months

Study Arms (3)

Hypogastric artery ligation (HAL)

Patients who underwent only hypogastric artery ligation performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC)

Procedure: hypogastric artery ligation

HAL and hysterectomy

Patients who underwent both hypogastric artery ligation and hysterectomy performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC)

Procedure: hypogastric artery ligation

Postpartum

Postpartum control group constituted of patients delivered baby without any complication and evaluated 6 months later.

Interventions

hypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation

Also known as: hysterectomy
HAL and hysterectomyHypogastric artery ligation (HAL)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll participants are females undergoing delivery of their baby
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who had hypogastric artery ligation and/or hysterectomy during their delivery. Control group is age-matched postpartum patients.

You may qualify if:

  • age 18- 40 years
  • no systemic or endocrine diseases
  • patients who had hypogastric artery ligation and/or hysterectomy
  • healthy postpartum patients as controls

You may not qualify if:

  • history of chemotherapy and/or radiotherapy
  • Obese patients
  • patients with previous/present endometriosis
  • patients with PCOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SSTRH

Istanbul, 34303, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Hysterectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Alev Atıs, MD,ObGyn

    Kanuni Sultan Suleyman Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,ObGYN

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

March 20, 2017

Primary Completion

September 20, 2017

Study Completion

September 29, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations