Maternal and Neonatal Outcomes After Membrane Sweeping

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01828853

Acronym

Stripping

Enrollment

1200

Registered

2013-04-11

Start date

2013-04-30

Completion date

2013-12-31

Last updated

2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Sepsis

Keywords

Membrane sweeping, Membrane stripping, Maternal outcomes, Neonatal outcomes

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

17 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Israel

Contacts

Primary ContactDoron Kabiri, MD

doronkabiri@gmail.com00972-508946898

Backup ContactHadas Lemberg, PhD

lhadas@hadassah.org.il00 972 2 6777572

Outcome results