NCT03591159

Brief Summary

Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. In these study, investigators investigate the effect of membrane sweeping on the need of induction and the delivery time in term pregnancy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 29, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

June 19, 2018

Last Update Submit

August 30, 2025

Conditions

Delivery, Obstetric

Outcome Measures

Primary Outcomes (2)

  • Need of Labor Induction.

    Patient need induction for delivery or not. If the patient reach 40 weeks 6 days for gestational age and spontaneous delivery doesn't begin spontaneously, labor induction is needed.

    During pregnancy. 40 weeks and 6 days for gestational age

  • Duration of delivery

    The time of the latent and active stage of delivery

    During delivery

Study Arms (2)

Membrane Sweeping Group

ACTIVE COMPARATOR
Other: Membran Sweeping

Control Group

NO INTERVENTION

Interventions

Membran SweepingOTHER

Cervical Membrane Sweeping by digital examination

Membrane Sweeping Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • Vertex presentation
  • No contraindication for vaginal delivery
  • No contraindication for labor induction

You may not qualify if:

  • Active vaginal infection
  • Previous uterine surgery
  • Systemic disease
  • Multiple pregnancy
  • Fetal anomaly and suspicious fetal health status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School of Medicine Department of Obstetrics and Gynecology

Ankara, 06590, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Principal Investigator

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 19, 2018

Study Start

May 29, 2018

Primary Completion

January 1, 2020

Study Completion

December 1, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations

TU(1)