Maternal and Neonatal Outcomes After Membrane Sweeping

• Conditions: Sepsis; Infection

• Registration Number: NCT01828853
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-01-30
• Status Verified: 2013-03
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-08
• Last Update Submitted: 2013-04-08
• Study First Posted: 2013-04-11
• Last Update Posted: 2013-04-11
• Primary Completion: 2013-08
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neonatal sepsis	Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days

Secondary Outcome Measures

Name	Time	Method
Neonatal infection	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.

Trial Locations

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel