Sweeping the Membranes, Cervical Length and Duration of Labor

Disorder of Amniotic Cavity and/or Membrane Clinical Trial

Official title:

The Impact of Sweeping the Membranes on Cervical Length and Labor: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309308
• Other study ID #: KA 09/248
• Status: Completed
• Phase: N/A
• First received: March 4, 2011
• Last updated: October 3, 2011
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery.

Description:

Cervical length will be measured in both groups. The membranes will be swept in pregnancies beyond 38 weeks by digital examination in the study group. The control group will only be examined for Bishop score. Two days later cervical length will be Measured once more.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.

Exclusion Criteria:

• Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Amniotic Cavity and/or Membrane

Intervention

Procedure:
• sweeping the membranes
The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.

Other:
• No sweeping group
Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.

Locations

Country	Name	City	State
Turkey	Baskent Universitesi Seyhan Arastirma ve Uygulama Hastanesi	Adana

Sponsors (2)

Lead Sponsor	Collaborator
Huriye Ayse Parlakgumus	Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical Shortening	Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.	2days	No
Secondary	The Duration of Latency Until Labor	The period (in days) from the last cervical measurement to the start of second phase of labor.	15 days	No