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
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Condition or disease |
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Sepsis Infection |
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 |
- Neonatal sepsis [ Time Frame: Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days ]
- 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.

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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 |
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.

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
Contact: Doron Kabiri, MD | 00972-508946898 | doronkabiri@gmail.com | |
Contact: Hadas Lemberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
Israel | |
Hadassah Medical Organization, Jerusalem, Israel | |
Jerusalem, Israel | |
Contact: Kabiri doronkabiri@gmail.com |
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 |
Membrane sweeping Membrane stripping Maternal outcomes Neonatal outcomes |