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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768142
• Other study ID #: 00137-15-EMC
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: August 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Other:
• Natural cesarean delivery
Natural cesarean delivery
• Standard cesarean delivery
Standard cesarean delivery

Locations

Country	Name	City	State
Israel	Department of Ob/Gyn, Ha`Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Raed Salim

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level after delivery	Difference between pre- and post-surgical hemoglobin levels.	4 days
Secondary	Blood product transfusion	Number of Packed red blood cells and plasma products	4 days
Secondary	Pain score during the operation		1 hour
Secondary	Pain score during the first day after cesarean delivery	Use of analgesic drugs	24 hours
Secondary	Analgesia use during the operation	Use of analgesic drugs	1 hour
Secondary	Analgesia use during the first day after cesarean delivery		24 hours
Secondary	Rate of breastfeeding at maternal hospital discharge		4 days
Secondary	Rate of breastfeeding 6 months after delivery		6 months
Secondary	Maternal satisfaction of the delivery	Satisfaction scale	4 days
Secondary	Breast engorgement	Diagnosed by physical examination	4 days
Secondary	Neonatal temperature after delivery	Temperature	1 hour