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

Study Overview
=================
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.

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

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Other: Natural cesarean delivery
* Other: Standard cesarean delivery


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |