Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery

Not Applicable

• Conditions: Placental Blood Drainage
• Interventions: Procedure: Placental Blood Drainage; Procedure: not Placental Blood Drainage

• Registration Number: NCT03020355
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.

Detailed Description

The patients will prospectively randomized equally into two groups (100 each in the study and control groups).

Group-A (Study group)-Placental blood was drained.

Group-B (Control group)-Placental blood was not drained.

In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.

Study Timeline

• Study First Submitted: 2016-12-22
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-13
• Last Update Posted: 2017-01-13
• Study Start: 2017-02
• Primary Completion: 2017-05
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Singleton pregnancy
• Vertex presentation
• Gestational age of 37 weeks (or) more
• No major medical (or) obstetric complications
• Spontaneous vaginal delivery

Exclusion Criteria

• Hb\7 gm/dl
• History of APH
• Instrumental delivery
• Multiple pregnancy
• Malpresentations
• Large baby (more than 3.5 kg)
• Polyhydramnios
• Known coagulations disorders
• Previous surgeries on the uterus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placental Blood Drainage	Placental Blood Drainage	Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
not Placental Blood Drainage	not Placental Blood Drainage	In the control group, the clamped cord will not released.

Primary Outcome Measures

Name	Time	Method
Blood lost	through delivery completion, an average of 30 minutes

Secondary Outcome Measures

Name	Time	Method
The duration of the third stage	through the duration of the third stage, an average 45 minutes	The duration of the third stage will calculated using a stop watch.