NCT01828853

Brief Summary

This study aim to estimate maternal and neonatal outcomes after membrane sweeping in different group of patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 30, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 11, 2013

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

January 30, 2013

Last Update Submit

April 8, 2013

Conditions

SepsisInfection

Keywords

Membrane sweepingMembrane strippingMaternal outcomesNeonatal outcomes

Outcome Measures

Primary Outcomes (1)

  • Neonatal sepsis

    Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days

Secondary Outcomes (1)

  • Neonatal infection

    Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days

Eligibility Criteria

Age17 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

SepsisInfections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Doron Kabiri, MD

CONTACT

00972-508946898doronkabiri@gmail.com

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

April 11, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

April 11, 2013

Record last verified: 2013-03

Locations

IL(1)