NCT03229304

Brief Summary

The aim of the study is to evaluate the uterine artery doppler just before labour in term low risk pregnancies. And to investigate with this measurement if investigators could foreseen the amount of postpartum hemorrhage looking at decreased in the hematocrit values.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
Last Updated

July 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

July 14, 2017

Last Update Submit

July 21, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • To measure the uterine artery Pulsatility index in term pregnant women

    With ultrasonography uterine artery doppler Pulsatility index (cm/s) will be measure

    6-8 hour before the delivery

  • To measure the uterine artery Resistant index (cm/s) in term pregnant women

    With ultrasonography uterine artery doppler Resistant index will be measure

    6-8 hour before the delivery

  • To measure the uterine artery mean systolic/diastolic volume (cm/s) in term pregnant women

    With ultrasonography Uterine artery doppler Mean systolic/diastolic volume (cm/s) ) will be measure

    6-8 hour before the delivery

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The pregnant women that is term and have no risk factors for postpartum hemorrhage

You may qualify if:

  • singleton term pregnancies

You may not qualify if:

  • polyhydramnios
  • Large for gestational age fetuses
  • multiple pregnancies
  • preterm labour
  • chorioamnionitis
  • history of atonia or postpartum hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerem Doga Seckin

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Kaplanoglu M, Karateke A, Un B, Gunsoy L, Baloglu A. Evaluation of uterine artery recanalization and doppler parameters after bilateral uterine artery ligation in women with postpartum hemorrhage. Int J Clin Exp Med. 2015 May 15;8(5):7823-9. eCollection 2015.

    PMID: 26221335BACKGROUND
  • Yildirim D, Ozyurek SE, Ekiz A, Eren EC, Hendem DU, Bafali O, Seckin KD. Comparison of active vs. expectant management of the third stage of labor in women with low risk of postpartum hemorrhage: a randomized controlled trial. Ginekol Pol. 2016;87(5):399-404. doi: 10.5603/GP.2016.0015.

    PMID: 27304659BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass prof

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 25, 2017

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

July 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations