Maternal and Neonatal Outcomes After Membrane Sweeping (Stripping)

April 8, 2013 updated by: Hadassah Medical Organization
This study aim to estimate maternal and neonatal outcomes after membrane sweeping in different group of patients.

Study Overview

Status

Unknown

Conditions

Detailed Description

Sweeping of the membranes is a simple technique usually performed during vaginal examination, in order to initiate labour by increasing local production of prostaglandins.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All women presenting to the Maternal-fetal unit who are 37+ weeks gestation

Description

Inclusion Criteria:

  • Women with a singleton pregnancy and confirmed cephalic presentation at or after 37 weeks of gestation who are candidate for vaginal delivery were eligible for the study

Exclusion Criteria:

  • Women with a multiple pregnancy, nonreassuring cardiotocogram, meconium stained amniotic fluid, major fetal anomalies, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, or severe preeclampsia and signs of intrauterine infections were not eligible.
  • women who are not candidates for vaginal delivery: placenta previa, breech presentation, planned repeat cesarean.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal sepsis
Time Frame: Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days
Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal infection
Time Frame: Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days
Neonates with two or more of the following signs: Altered behaviour or responsiveness, Altered muscle tone (floppiness), Feeding difficulties, Feed intolerance (vomiting, excessive gastric aspirates, abdominal distension), Abnormal heart rate (bradycardia or tachycardia), Signs of respiratory distress, Hypoxia (central cyanosis or reduced oxygen saturation level), Jaundice, Apnoea, Signs of neonatal encephalopathy, Seizures, Need for cardio-pulmonary resuscitation, Low-temperature (lower than 36°C), High-temperature (higher than 38°C), Signs of shock, Unexplained excessive bleeding, thrombocytopenia or abnormal coagulation, Oliguria, Altered glucose homeostasis (hypoglycaemia or hyperglycaemia), Metabolic acidosis, Local signs of infection.
Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Kabiri-Stripping-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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