Delayed Cord Clamping and Use of Oxytocin

Placental Transfusion Clinical Trial

Official title:

Is Placental Transfusion Influenced by the Early Administration of Oxytocin?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02618499
• Other study ID #: Funda05
• Status: Terminated
• Phase: Phase 3
• First received: November 10, 2015
• Last updated: November 22, 2016
• Start date: May 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Fundacion para la Salud Materno Infantil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.

Description:

Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion.

Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped.

The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion.

In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy single Term pregnancies.

• Vaginal delivery.

• Informed consent obtained.

• Presence of an investigator

Exclusion Criteria:

• Placenta previa.

• Previous history of Postpartum hemorrhage

• Intrauterine growth restriction .

• Major congenital malformations.

• Eclampsia

• Extraction of blood sample for bank of umbilical cord stem cells.

Elimination criteria:

• Need for immediate assistance of the newborn

• Birth weight less than 2500 g

• Nuchal cord wrapped too tight

• Surgically finished delivery

• Short umbilical cord which might prevent placing the infant on the scale

• Technical difficulties to obtain the weight

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Placental Transfusion

Intervention

Drug:
• Timing of administration of post partum Oxytocin
10 IU of oxytocin given IV at different times after birth

Locations

Country	Name	City	State
Argentina	Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced	San Miguel de Tucuman	Tucuman

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Salud Materno Infantil

Country where clinical trial is conducted

Argentina, 

References & Publications (9)

Begley CM, Gyte GM, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2015 Mar 2;(3):CD007412. doi: 10.1002/14651858.CD007412.pub4. Review. — View Citation

Farrar D, Airey R, Law GR, Tuffnell D, Cattle B, Duley L. Measuring placental transfusion for term births: weighing babies with cord intact. BJOG. 2011 Jan;118(1):70-5. doi: 10.1111/j.1471-0528.2010.02781.x. — View Citation

Lalonde A; International Federation of Gynecology and Obstetrics.. Prevention and treatment of postpartum hemorrhage in low-resource settings. Int J Gynaecol Obstet. 2012 May;117(2):108-18. doi: 10.1016/j.ijgo.2012.03.001. — View Citation

McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;(7):CD004074. doi: 10.1002/14651858.CD004074.pub3. Review. — View Citation

Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2. Review. — View Citation

Trudnowski RJ, Rico RC. Specific gravity of blood and plasma at 4 and 37 degrees C. Clin Chem. 1974 May;20(5):615-6. — View Citation

Vain NE, Satragno DS, Gorenstein AN, Gordillo JE, Berazategui JP, Alda MG, Prudent LM. Effect of gravity on volume of placental transfusion: a multicentre, randomised, non-inferiority trial. Lancet. 2014 Jul 19;384(9939):235-40. doi: 10.1016/S0140-6736(14)60197-5. — View Citation

Westhoff G, Cotter AM, Tolosa JE. Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Oct 30;(10):CD001808. doi: 10.1002/14651858.CD001808.pub2. Review. — View Citation

Yao AC, Hirvensalo M, Lind J. Placental transfusion-rate and uterine contraction. Lancet. 1968 Feb 24;1(7539):380-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	placental transfusion	Difference in body weight between birth and 3 minutes of life	between birth and 3 minutes of life	No
Secondary	bilirubin	Bilirubin level	at 36/48 hours	No
Secondary	Hematocrit	Hematocrit levels	at 36/48 hours	No
Secondary	Maternal blood loss	measure of the blood loss	after birth for 30 minutes	Yes

External Links

•   WHO recommendations