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Maternal and Neonatal Outcomes After Membrane Sweeping (Stripping)

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ClinicalTrials.gov Identifier: NCT01828853
Recruitment Status : Unknown
Verified March 2013 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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Brief Summary:
This study aim to estimate maternal and neonatal outcomes after membrane sweeping in different group of patients.

Condition or disease
Sepsis Infection

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Maternal and Neonatal Outcomes After Membrane Sweeping
Study Start Date : April 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Neonatal sepsis [ Time Frame: Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days ]

Secondary Outcome Measures :
  1. Neonatal infection [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All women presenting to the Maternal-fetal unit who are 37+ weeks gestation
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828853


Contacts
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Contact: Doron Kabiri, MD 00972-508946898 doronkabiri@gmail.com
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
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Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Contact: Kabiri       doronkabiri@gmail.com   
Sponsors and Collaborators
Hadassah Medical Organization
More Information
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Additional Information:

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01828853    
Other Study ID Numbers: Kabiri-Stripping-HMO-CTIL
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: March 2013
Keywords provided by Hadassah Medical Organization:
Membrane sweeping
Membrane stripping
Maternal outcomes
Neonatal outcomes