Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome
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ClinicalTrials.gov Identifier: NCT05951348 |
Recruitment Status :
Completed
First Posted : July 19, 2023
Last Update Posted : July 21, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Umbilical Cord Milking | Procedure: Delayed cord clamping for 30 seconds | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome |
Actual Study Start Date : | November 11, 2021 |
Actual Primary Completion Date : | June 20, 2022 |
Actual Study Completion Date : | June 20, 2022 |
Arm | Intervention/treatment |
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No Intervention: Immediate cord clamping
this arm where the patient didn't receive any special maneuver and immediate cord clamping after delivery of the fetus is done
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Experimental: Delayed cord clamping
this arm where the patient receive a delay in cord clamping for 30 seconds after delivery of the fetus
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Procedure: Delayed cord clamping for 30 seconds
waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds
Other Name: Umbilical cord milking |
Experimental: Umbilical cord milking
this arm where the patient receive stripping of the umbilical cord in the direction of the fetus 10 times in a time frame 10-15 seconds after delivery of the fetus
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Procedure: Delayed cord clamping for 30 seconds
waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds
Other Name: Umbilical cord milking |
- hemoglobin level [ Time Frame: immediately after the intervention ]a blood sample is taken from the umbilical cord of the neonate
- bilirubin level [ Time Frame: 72 hours after delivery ]trans-cutaneous measurement of the bilirubin level
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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- mother's age (20-40) years.
- pregnancy with a healthy singleton
- gestational age of 38-41 0/7 weeks
- uncomplicated pregnancy
Exclusion Criteria
- Any medical or obstetrical complications like hypertension, pre-eclampsia, diabetes any special habits like smoking, and substance abuse
- Rh-negative mothers. The fetal exclusion criteria
- fetus with evidence of intrauterine growth restriction
- infant with serious congenital anomalies.
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): NCT05951348
Egypt | |
Tamer Ahmed Hosny | |
Alexandria, Egypt |
Responsible Party: | Alexandria University |
ClinicalTrials.gov Identifier: | NCT05951348 |
Other Study ID Numbers: |
0106748 |
First Posted: | July 19, 2023 Key Record Dates |
Last Update Posted: | July 21, 2023 |
Last Verified: | May 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cesarean section umbilical cord milking hemoglobin |