Maternal and Neonatal Outcomes After Membrane Sweeping

Hadassah Medical Organization1,200 enrolled

Overview

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

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

1,200

Conditions

Sepsis Infection

Eligibility

Sex: FEMALEMin age: 17 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Outcomes

Primary Outcomes

Neonatal sepsis

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

Secondary Outcomes

Neonatal infection

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.

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

Central Contacts

Doron Kabiri, MD

CONTACT

00972-508946898 doronkabiri@gmail.com

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572 lhadas@hadassah.org.il

Data from ClinicalTrials.gov

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