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

The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Other: Natural cesarean delivery; Other: Standard cesarean delivery

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Natural cesarean delivery; Placing the neonate on maternal chest immediately after the extraction from the uterus, and permitting breastfeeding during surgery.	Other: Natural cesarean delivery; Natural cesarean delivery
Active Comparator: Standard cesarean delivery; Presentation of the neonate to the mother during the operation.	Other: Standard cesarean delivery; Standard cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin level after delivery	Difference between pre- and post-surgical hemoglobin levels.	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood product transfusion	Number of Packed red blood cells and plasma products	4 days
Pain score during the operation		1 hour
Pain score during the first day after cesarean delivery	Use of analgesic drugs	24 hours
Analgesia use during the operation	Use of analgesic drugs	1 hour
Analgesia use during the first day after cesarean delivery		24 hours
Rate of breastfeeding at maternal hospital discharge		4 days
Rate of breastfeeding 6 months after delivery		6 months
Maternal satisfaction of the delivery	Satisfaction scale	4 days
Breast engorgement	Diagnosed by physical examination	4 days
Neonatal temperature after delivery	Temperature	1 hour

Collaborators and Investigators

• Sponsor: Raed Salim
• Investigators: Study Chair: Raed Salim, MD, Emek Medical Center, Afula, Israel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: April 24, 2016
• First Submitted That Met QC Criteria: May 8, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 00137-15-EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED