Clinical Trials Directory

Trials / Terminated

TerminatedNCT01497340

Position at Birth,Placental Transfusion Volume and Cord Clamping

Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth? a Pilot Study

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Fundacion para la Salud Materno Infantil · Academic / Other
Sex
All
Age
2 Minutes
Healthy volunteers
Accepted

Summary

To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.

Detailed description

Pilot study. Randomized controlled trial not blind, in one center. Informed consent will be obtained during pregnancy or admittance and previous to birth. Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus Term newborns by vaginal delivery and without complications with cord clamping at 2 minutes after birth. Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level). Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to. In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight. Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement. In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion of the umbilical cord at 120 seconds after birth and then a new Weight will be obteined after clamping.

Conditions

Interventions

TypeNameDescription
OTHERPosition at introitus levelAfter birth: Weight at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec Weight after clamping
OTHERPosition at Maternal AbdomenNewborns weight's difference between having them weighed immediately after birth and when cord is clamped in both positions(introitus and abdomen).

Timeline

Start date
2010-10-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2011-12-22
Last updated
2011-12-22

Locations

1 site across 1 country: Argentina

Source: ClinicalTrials.gov record NCT01497340. Inclusion in this directory is not an endorsement.