The Effect of Membrane Sweeping on the Delivery Time and... | NCT03591159

Studies
The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy

NCT03591159

Sponsor

Ankara University

Status

Active, not recruiting

Last Update Posted

Sep 8, 2025Actual

Enrollment

256Estimated

Phase

Not Applicable

Conditions

Delivery, Obstetric

Interventions

Membran Sweeping

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2018Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jun 19, 2018

First Submission Date that Met QC Criteria

Jul 8, 2018

First Posted Date

Jul 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2025

Last Update Posted Date

Sep 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

256Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Membrane Sweeping Group	Active Comparator		Other: Membran Sweeping
Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Membran Sweeping	Other	Cervical Membrane Sweeping by digital examination	Membrane Sweeping Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara University School of Medicine Department of Obstetrics and Gynecology		Ankara		06590	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

At the end of the study, participant data access is possible by online.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided