Uterine Massage After Vaginal Delivery

NCT ID: NCT03858569

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The participants will be randomized into an oxytocin plus uterine massage group and an oxytocin-only group in the third stage of the labor. Women allocated to the uterine massage group will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. The amount of postpartum hemorrhage and placental delivery time will be recorded and compared between the groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Women allocated to oxytocin only group will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus. Women allocated to the oxytocin plus uterine massage group will be will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus and will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. Collection of blood loss will be initiated immediately after delivery of the fetus by putting a drape under the woman's buttocks. Collected blood will be weighed and the amount will be recorded in grams.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxytocin

10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus

Group Type ACTIVE_COMPARATOR

active management of third stage of labor

Intervention Type PROCEDURE

Active management of the third stage of the labor will be done administering oxytocin and cord traction.

Oxytocin plus uterine massage

10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed.

Group Type ACTIVE_COMPARATOR

active management of third stage of labor

Intervention Type PROCEDURE

Active management of the third stage of the labor will be done administering oxytocin and cord traction.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

active management of third stage of labor

Active management of the third stage of the labor will be done administering oxytocin and cord traction.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-40 years old women delivering vaginally

Exclusion Criteria

* women with bleeding disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Berna Aslan Cetin

Md, ObGYN, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kanuni SSTRH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Kadirogullari P, Aslan Cetin B, Goksu M, Cetin Arslan H, Seckin KD. The effect of uterine massage after vaginal delivery on the duration of placental delivery and amount of postpartum hemorrhage. Arch Gynecol Obstet. 2024 Jun;309(6):2689-2695. doi: 10.1007/s00404-023-07211-5. Epub 2023 Sep 12.

Reference Type DERIVED
PMID: 37698604 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/11/42

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.