NCT07279545

Brief Summary

The aim of the study was to evaluate the effect of controlled placental cord drainage by opening the clamp at the maternal end after the umbilical cord is cut during birth on the duration of the third stage of labor (departure of the placenta), the amount of blood loss in the third stage, the amount of bleeding in the 2nd hour postpartum, and the development of postpartum complications.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Nov 2025Jul 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 17, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 14, 2025

Last Update Submit

December 9, 2025

Conditions

Postpartum Hemorrhage

Keywords

active managementthird stage of laborplacental cord drainagepostpartum hemorrhage

Outcome Measures

Primary Outcomes (3)

  • Determining the duration of the third stage of labor

    In the intervention and control groups, the time of placental delivery will be recorded using a digital clock. The time between the birth of the newborn and the delivery of the placenta will constitute the duration of the third stage of labor.

    The time between the birth of the newborn and the delivery of the placenta

  • Determining the amount of blood lost in the 3rd stage

    In the control group, the blood collected in the V-drop (ml) will be measured and calculated. In the intervention group, the placental drainage blood collected in the kidney basin (grams) will be added to the blood collected in the V-drop (ml). The total amount of blood loss will be calculated in ml. The blood in the kidney basin will be calculated in ml as follows: (The weight of the kidney basin filled with blood after taring ÷ 1.05) (Asıcıoğlu et al, 2015).

    Until one of the signs of placental separation is seen, maximum 5 minutes

  • Determination of the amount of hemorrhage at the 2nd hour postpartum

    At the end of the second hour postpartum, the leak-proof underwear will be removed and weighed on a precision scale. The amount of blood lost at this stage will be calculated in ml as follows: (The weight of the leak-proof absorbent underwear used - the weight before use) ÷ 1.05. (Asıcıoglu et al, 2015).

    Postpartum 0-2 hours

Secondary Outcomes (3)

  • Hemoglobin and hematocrit levels at 24 hours postpartum, changes compared to prepartum

    Admission to the delivery room - postpartum 24th hour

  • The possibility of developing complications in the third stages of labor

    The time from the moment of placental cord drainage until placental separation

  • The possibility of developing complications in the fourth stage of labor

    Postpartum until the 24th hour after delivery of the placenta

Study Arms (2)

Placental Cord Drainage Group

EXPERIMENTAL

In the intervention group, after the cord is cut, the clamp remaining at the maternal end will be released, allowing for controlled placental drainage into the kidney basin. This procedure will continue until signs of placental separation are observed. If at least one of these signs of separation is observed, the cord will be re-clamped. Signs of separation are expected to occur within 5 minutes, but if no signs of separation are observed within 5 minutes, the procedure will be terminated and the cord will be re-clamped. The midwife will remain with the patient at all times during this period.

Procedure: Placental cord drainage

Control Group

NO INTERVENTION

In the women in the control group, the more routine practice in the clinic will be applied, that is, the umbilical cord will remain clamped until the placenta is delivered.

Interventions

Placental cord drainagePROCEDURE

Placental cord drainage is the process of clamping and cutting the umbilical cord after the birth of the baby, then opening the clamp at the maternal end of the cord and allowing the blood in the placenta to flow outward (Soltani et al, 2011; Vasconcelos et al, 2018; Pandey et al, 2019; Upadya et al, 2019; Chaudhary et al, 2020; Kazı et al, 2020; Mittal et al, 2020; Nabıl and Marzouk, 2020; Mansour et al, 2021; El Sayed et al, 2021; Karimi et al, 2022; Wedn and Hassanin, 2022).

Placental Cord Drainage Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants will be included in this study because the condition under investigation occurs exclusively in woman.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No problem speaking and understanding Turkish
  • Low-risk pregnant women
  • Vertex presentation
  • st weeks of gestation
  • There are no complications in the mother or the baby that prevent normal birth.
  • The VAS score for the pain felt by the pregnant woman at the time of admission to the study must be less than 3 (to show that the pregnant women were accepted into the study at a time when their pain was at its lowest and their decision-making ability was at a relatively good level)

You may not qualify if:

  • History of postpartum hemorrhage
  • History of postpartum hemorrhage in mother or sister
  • Birth interval less than 2 years
  • Anticoagulant use during pregnancy
  • Smoking during pregnancy
  • Those with low Hb values (Hb\<11gr/dL)
  • Hematocrit \<30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Maternity and Child Diseases Hospital

Zonguldak, Zonguldak/Centre, 67030, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ferhat TÜFEKÇİ, Spc. Dr.

    Zonguldak Maternity and Child Diseases Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinem GÜLTEKİN, Phd

CONTACT

05546531112sinemgultekin06@gmail.com

Nazan KARAHAN, Prof. Dr.

CONTACT

05074861414nazan.karahan@sbu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Two groups with a intervention and control
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sp. Midwife

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 12, 2025

Study Start

November 17, 2025

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations

TU(1)