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The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Natural cesarean delivery
Standard cesarean delivery
Sponsored by
Raed Salim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

8 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Estimated to be appropriate for gestational age fetus.
  • Sonographic dating before 20 weeks of gestation.

Exclusion Criteria:

  • Non-scheduled CD.
  • Major fetal malformations.
  • Multiple gestations.
  • Non-controlled diabetes.
  • Severe pre-eclampsia.
  • General anesthesia.
  • HIV carrier
  • Neonatal need for early resuscitation.

Sites / Locations

  • Department of Ob/Gyn, Ha'Emek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Natural cesarean delivery

Standard cesarean delivery

Arm Description

Placing the neonate on maternal chest immediately after the extraction from the uterus, and permitting breastfeeding during surgery.

Presentation of the neonate to the mother during the operation.

Outcomes

Primary Outcome Measures

Hemoglobin level after delivery
Difference between pre- and post-surgical hemoglobin levels.

Secondary Outcome Measures

Blood product transfusion
Number of Packed red blood cells and plasma products
Pain score during the operation
Pain score during the first day after cesarean delivery
Use of analgesic drugs
Analgesia use during the operation
Use of analgesic drugs
Analgesia use during the first day after cesarean delivery
Rate of breastfeeding at maternal hospital discharge
Rate of breastfeeding 6 months after delivery
Maternal satisfaction of the delivery
Satisfaction scale
Breast engorgement
Diagnosed by physical examination
Neonatal temperature after delivery
Temperature

Full Information

First Posted
April 24, 2016
Last Updated
August 20, 2019
Sponsor
Raed Salim
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1. Study Identification

Unique Protocol Identification Number
NCT02768142
Brief Title
The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.
Official Title
The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raed Salim

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Throughout the history, the neonate was dependent on maternal touch and care for survival. In modern obstetrics, with hospital care the neonates are seldom separated from their mothers after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk production, lactation and improve maternal and neonatal outcome. Oxytocin is the primary hormone responsible for uterine contraction and prevention of postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion. The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was found to decrease postpartum milk production, postpones early lactation and decreases exclusive breastfeeding. During the typical CD, the neonate is usually presented for a short while to the mother and breastfeeding is usually delayed at least a number of hours until after the surgery and the recovery period. Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin secretion increases with ESTS and during breastfeeding. The aim of this study is to examine blood loss that occurs after Natural CD compared to standard CD without an ESTS contact.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natural cesarean delivery
Arm Type
Experimental
Arm Description
Placing the neonate on maternal chest immediately after the extraction from the uterus, and permitting breastfeeding during surgery.
Arm Title
Standard cesarean delivery
Arm Type
Active Comparator
Arm Description
Presentation of the neonate to the mother during the operation.
Intervention Type
Other
Intervention Name(s)
Natural cesarean delivery
Intervention Description
Natural cesarean delivery
Intervention Type
Other
Intervention Name(s)
Standard cesarean delivery
Intervention Description
Standard cesarean delivery
Primary Outcome Measure Information:
Title
Hemoglobin level after delivery
Description
Difference between pre- and post-surgical hemoglobin levels.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Blood product transfusion
Description
Number of Packed red blood cells and plasma products
Time Frame
4 days
Title
Pain score during the operation
Time Frame
1 hour
Title
Pain score during the first day after cesarean delivery
Description
Use of analgesic drugs
Time Frame
24 hours
Title
Analgesia use during the operation
Description
Use of analgesic drugs
Time Frame
1 hour
Title
Analgesia use during the first day after cesarean delivery
Time Frame
24 hours
Title
Rate of breastfeeding at maternal hospital discharge
Time Frame
4 days
Title
Rate of breastfeeding 6 months after delivery
Time Frame
6 months
Title
Maternal satisfaction of the delivery
Description
Satisfaction scale
Time Frame
4 days
Title
Breast engorgement
Description
Diagnosed by physical examination
Time Frame
4 days
Title
Neonatal temperature after delivery
Description
Temperature
Time Frame
1 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Estimated to be appropriate for gestational age fetus. Sonographic dating before 20 weeks of gestation. Exclusion Criteria: Non-scheduled CD. Major fetal malformations. Multiple gestations. Non-controlled diabetes. Severe pre-eclampsia. General anesthesia. HIV carrier Neonatal need for early resuscitation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raed Salim, MD
Organizational Affiliation
Emek Medical Center, Afula, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Ob/Gyn, Ha'Emek Medical Center
City
Afula
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35398585
Citation
Zafran N, Garmi G, Abdelgani S, Inbar S, Romano S, Salim R. Impact of "natural" cesarean delivery on peripartum blood loss: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100642. doi: 10.1016/j.ajogmf.2022.100642. Epub 2022 Apr 8.
Results Reference
derived

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The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.

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