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Completed

NCT Number: NCT03542292

Placental Drainage Versus no Placental Drainage After Vaginal Delivery in the Management of Third Stage of Labour

In this randomized controlled study, 222 pregnant women who admitted to Zeynep Kamil Women and Children's Health Training and Research Hospital from December 2016 and July 2017 were included. They were randomized into study(111) or control(111) group when they delivered vaginally. In study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. In control group the umblical cord was clamped both sides.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

This was a randomized controlled trial on 222 pregnant women who admitted to our hospital from December 2016 and July 2017. After approval of the ethics committee and written consent of the patients were taken, 222 pregnant women were included in this study. They were randomized into study(111) or control(111) group when they delivered vaginally. Randomization was performed by means of a computer-generated randomization table.

In study group; umbilical cord was clamped from fetal side but unclamped from maternal side. After that unclamped side of umblical cord was left open to drain the blood until the flow ceased. The blood was collected in the metal bowl and measured using a measuring jar. Care was taken not to mix the drained blood from the cord with the blood lost during the third stage. In control group the umblical cord was clamped both sides.

The inclusion criteria were>37 weeks of gestation, singleton, alive pregnancy, with vertex presentation expected to have spontaneous vaginal delivery. The exclusion criteria were fetal malpresentation, history of postpartum hemorrhage, preterm delivery, multiple pregnancy, fetal anomaly, uterine malformation, fetal demise, women with immediate delivery indications, unable to give written informed consent, a clinically estimated fetal weight >4500, preeclampsia, antepartum hemorrhage, previous cesarean section, instrumental delivery and known coagulation disorders. Patients were recruited regardless of using cervical ripening agents.

General physical and obstetric examination were performed after a detailed history taking. A sample of venous blood was obtained for hemoglobin concentration on admission. Labour was conducted according to the hospital protocol. Labour was augmented with oxytocin in active phase of labour. All patients were monitored with cardiotocography (CTG) before induction of labor and CTG was used continuously during labor. Oxytocin infusion was continued until delivery of both child and placenta, unless complications occurred. For all patients, blood lost in the third stage of labour was measured by collecting the blood in a disposable conical measuring bag. The time of delivery of the neonate was recorded and after then prophylactic uterotonic agents (Synpitan Fort, 5 IU) was given to all patients. Placenta was delivered by controlled cord traction andthe time of placental delivery was noted in both groups. If the placenta had not been delivered spontaneously by 30 minutes after birth, it was removed manually. The vital signs(blood pressure, pulse rate, temperature) uterine tone of the patients were monitored after delivery of neonate and placenta. The hemoglobin concentration was estimated 24 hours after delivery.

The outcome measures were the duration of the third stage of labour, defined as interval from birth of the infant to delivery of the placenta, haemoglobin difference between admission and 24 hours after delivery, visual analog scale (VAS) scores, weight of placenta, need for blood transfusion, blood loss from umbilical cord and blood loss in the third stage of labour. PPH was defined as a loss of more than 500 mL of blood within the first 24 hours following childbirth.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>37 weeks of gestation, singleton, alive pregnancy, with vertex presentation expected to have spontaneous vaginal delivery -

Exclusion criteria

fetal malpresentation, history of postpartum hemorrhage, preterm delivery, multiple pregnancy, fetal anomaly, uterine malformation, fetal demise, women with immediate delivery indications, unable to give written informed consent, a clinically estimated fetal weight >4500, preeclampsia, antepartum hemorrhage, previous cesarean section, instrumental delivery known coagulation disorders.

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Treatment and study plan

placental drainage

Diagnostic Test

Primary outcomes

  1. the duration of the third stage of labour

    Time frame: minutes from baby delivery to delivery of the placenta

    interval from birth of the infant to delivery of the placenta

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

Doğumun üçüncü Evresinin yönetiminde Vajinal doğum sonrası Plasental Drenaja karşı Plasenta drenajı: Randomize Bir çalışma

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 31, 2018
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.