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Postpartum HemorrhageNCT07279545

The Effect of Placental Cord Drainage on the Third Stage of Labor and the Amount of Postpartum Bleeding

A study testing Placental cord drainage in people with Postpartum Hemorrhage, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
Placental cord drainage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Nov 2025to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • No problem speaking and understanding Turkish
  • Low-risk pregnant women
  • Vertex presentation
  • 37-41st 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sinem GÜLTEKİN, Phd contact

05546531112

sinemgultekin06@gmail.com

Nazan KARAHAN, Prof. Dr. contact

05074861414

nazan.karahan@sbu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Zonguldak Maternity and Child Diseases Hospital

    Zonguldak, Zonguldak/Centre, 67030

    Sinem GÜLTEKİN, PhD., 05546531112, sinemgultekin06@gmail.com

    Nazan KARAHAN, Prof. Dr., 05074861414, nazan.karahan@sbu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Although the third stage is the shortest stage of labor, it is also the riskiest. Prolonging this stage increases the risk of complications, particularly postpartum hemorrhage. Therefore, the duration of the third stage of labor should be as short as possible. Internationally accepted labor management guidelines, such as WHO and ACOG, recommend that active management be adopted to shorten the third stage of labor to prevent postpartum hemorrhage. Placental cord drainage is also mentioned in the literature as a method used to accelerate the delivery of the placenta by actively managing the third stage of labor. This method involves 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. It is suggested that this method will make the placenta smaller and more compact by reducing its volume, thus providing more effective contractions in the uterus and consequently, earlier separation and expulsion of the placenta with less blood loss. This method is implemented as national policy in 32% of maternity units in Belgium, 24% in Portugal, 15% in Norway and Spain, and approximately 14% in Ireland. In our country, physicians and midwives have also been observed using this method when signs of placental separation are delayed. To facilitate placental separation, they open the clamp at the maternal end and allow some blood to flow from the placenta.

A review of studies reveals conflicting results. A Cochrane review of three studies involving 1,257 women reported that placental cord drainage shortened the length of the third stage of labor by an average of three minutes and reduced blood loss by an average of 77 ml. A meta-analysis of nine randomized controlled trials confirmed the effectiveness of placental cord drainage in shortening the length of the third stage, but the results showed that it did not reduce blood loss. However, more recent studies have reached conflicting conclusions. While some studies have found that placental cord drainage produces a significant reduction in postpartum blood loss and the duration of the third stage of labor, others have reported that it has no effect in reducing postpartum blood loss and shortening the third stage of labor. In addition, in all studies conducted on the subject, the incidence of complications such as postpartum hemorrhage, placental retention, hand hallas, additional medication and blood transfusion requirement was found to be lower. However, further studies are needed to determine whether placental cord drainage is effective in shortening the duration of the third stage of labor and reducing postpartum hemorrhage. Therefore, this study aimed to evaluate the effect of placental cord drainage on the third stage of labor and the amount of postpartum hemorrhage.

The study's results are significant because they add to the growing body of evidence by offering a new perspective on a controversial topic. The interventions implemented in this study are expected to result in a quicker delivery of the placenta, less bleeding, and a lower risk of postpartum complications. All of these benefits will contribute to a smoother delivery process. Complications experienced during the third stage can lead to anemia, necessitate blood transfusions, and delay the initiation of breastfeeding, affecting the health of the newborn. Considering the impact of all these negative effects on hospital costs, the national economy, and health indicators, it would be meaningful to expand the use of placental cord drainage in clinics for the active management of the third stage of labor, provided its effectiveness is demonstrated. Furthermore, considering its minimal effort, low cost, and its potential as an alternative midwifery method in regions where access to oxytocin and methergine is not available, widespread adoption is significant.

Data Collection

When pregnant women are admitted to the delivery room, the purpose, importance, and procedures of the study will be explained to those who meet the inclusion criteria. Written consent will be obtained from pregnant women who agree to participate. Pregnant women will then be assigned to either the intervention or control group based on their corresponding values in a simple random number table generated through www.random.org.

All pregnant women will then be administered a "Pregnancy Information Form," and the labor process will be monitored using a "Labor Monitoring and Evaluation Form." The start and end times of each stage of labor will be recorded using a digital clock, and the duration will be calculated. The time of birth will be considered the start of the third stage.

As soon as the baby is born, the V-drope blood collection bag will be placed appropriately under the woman's hips by the auxiliary staff.

All women in the intervention and control groups will receive prophylactic treatment determined by the physician's order, in accordance with hospital protocols (20 units of synpitan IV bolus in 500cc 5% dextrose).

The umbilical cord will be clamped and cut within 1 minute after the baby's birth.

In the intervention group, after the cord is cut, the clamp will be released, allowing placental drainage into the kidney basin in a controlled manner. This procedure will continue until signs of placental separation are observed. The cord will be re-clamped when at least one of these signs of separation is observed. 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 during this time. The placental drainage blood collected in the kidney basin will be measured using a precision digital scale, and the tare value of the kidney basin will be recorded.

In the women in the control group, the routine procedure will be performed, meaning the umbilical cord will remain clamped until the placenta is delivered.

While waiting for signs of placental separation in the intervention and control groups, the woman's pulse and blood pressure will be measured and recorded by another midwife.

In the intervention and control groups, after signs of placental separation appear, the placenta will be delivered using controlled cord traction (Brandt-Andrew maneuver). The cotyledons and membranes will be examined, and the placental thickness and weight will be measured. Uterine tone and bladder fullness will be assessed.

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 baby and the delivery of the placenta will constitute the duration of the third stage of labor.

The amount of blood lost in stage 3 will be calculated by measuring the blood collected in the V-drop in the control group (ml). 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 calculation of the blood in the kidney basin in ml will be made as follows: (The weight of the kidney basin filled with blood after taring ÷ 1.05).

If present, an episiotomy and repair of first- and second-degree lacerations will be performed. In cases where an episiotomy is necessary or first- or second-degree lacerations have occurred, blood from the episiotomy wounds or perineal lacerations will be tamponaded with a sponge and removed to avoid compromising the results.

After an episiotomy or laceration repair, the vaginal and perineal wound length will be measured and recorded with a disposable wound measuring ruler. A physician's order will then be administered according to hospital routines (1x2 amp IM methylerol (ergometrine) for all pregnant women whose blood pressure is not above 140-90 mm Hg). Women will then be dressed in absorbent, leak-proof underwear and taken to bed.

Women will remain under observation in the delivery room for the next two hours to monitor for any postpartum complications. After delivery, vital signs and uterine tone will be monitored according to hospital routine protocol.

Breastfeeding will be initiated within the first half hour after birth, and the start time and duration of breastfeeding will be recorded.

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: (Weight of the leak-proof absorbent underwear used - weight before use) ÷ 1.05.

Hb and Hct results of women in the intervention and control groups at the 24th hour after birth will be recorded from the patient file.

The amount of bleeding during pregnancy, as well as all postpartum measurements and assessments, will be performed and recorded by an assistant midwife who is unaware of the pregnant woman's group. This is intended to increase the reliability of the data.

Being tested
Placental cord drainage
Keywords
active management, third stage of labor, placental cord drainage, postpartum hemorrhage
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placental cord drainageProcedure or surgery

    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).

Study groups in NCT07279545
Study groupRoleWhat they receive
Placental Cord Drainage GroupExperimentalIn 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.
Receives: Procedure: Placental cord drainage
Control GroupNo interventionIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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).

    Measured: Postpartum 0-2 hours

Secondary outcomes (3)
  1. Hemoglobin and hematocrit levels at 24 hours postpartum, changes compared to prepartum

    Hb and Hct results of women in the intervention and control groups at the 24th hour after birth will be recorded from the patient file.

    Measured: Admission to the delivery room - postpartum 24th hour

  2. The possibility of developing complications in the third stages of labor

    Participants will be evaluated for complications such as hypotension, syncope, retained placenta, manual delivery of the placenta, and the need for additional medication.

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

  3. The possibility of developing complications in the fourth stage of labor

    Participants will be evaluated for complications such as atony, abnormal uterine bleeding, and the need for additional medication.

    Measured: Postpartum until the 24th hour after delivery of the placenta

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start17 Nov 2025
  3. Primary completion20 Jun 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07279545
Sponsor's protocol ID
GSBU-SBF-SG-01
Status last verified
Dec 2025
First submitted
14 Nov 2025
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Placental cord drainage in people with Postpartum Hemorrhage, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sinem GÜLTEKİN, Phd (05546531112, sinemgultekin06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determining the duration of the third stage of labor (time frame: The time between the birth of the newborn and the delivery of the placenta). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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