Maternal and Neonatal Outcomes After Membrane Sweeping

Sepsis Clinical Trial

— Stripping  

Official title:

Maternal and Neonatal Outcomes After Membrane Sweeping

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01828853
• Other study ID #: Kabiri-Stripping-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 30, 2013
• Last updated: April 8, 2013
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Hadassah Medical Organization
• Contact: Doron Kabiri, MD
• Phone: 00972-508946898
• Email: doronkabiri[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Sepsis

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal sepsis		Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days	Yes
Secondary	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.	Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days	Yes