Postpartum HemorrhageNCT03858569
Uterine Massage After Vaginal Delivery
A study testing active management of third stage of labor in people with Postpartum Hemorrhage, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- active management of third stage of labor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2019to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years old women delivering vaginally
Who cannot join
- women with bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery
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.
Read the detailed description
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
- Postpartum Hemorrhage
- Being tested
- active management of third stage of labor
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active management of third stage of laborProcedure or surgery
Active management of the third stage of the labor will be done administering oxytocin and cord traction.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | 10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus Receives: Procedure: active management of third stage of labor |
| Oxytocin plus uterine massage | Active comparator | 10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed. Receives: Procedure: active management of third stage of labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum hemorrhage
The amount of blood loss after delivery of the fetus
Measured: during procedure
Secondary outcomes (1)
Duration of third stage of the labor
Delivery of the fetus and delivery of the placenta interval
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start15 Jan 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858569
- Sponsor's protocol ID
- 2018/11/42
- Status last verified
- Jan 2024
- First submitted
- 27 Feb 2019
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37698604
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery
- ClinicalTrials.gov ID
- NCT03858569
- Acronym / sponsor ID
- 2018/11/42
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Procedure: active management of third stage of labor10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus |
| Oxytocin plus uterine massage | Active comparator | Procedure: active management of third stage of labor10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-40 years old women delivering vaginally
Key exclusion criteria (1 listed)
- women with bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active management of third stage of laborActive management of the third stage of the labor will be done administering oxytocin and cord traction. | Procedure or surgery | Oxytocin, Oxytocin plus uterine massage |
Primary outcome
Postpartum hemorrhage
Time frame: during procedure
The amount of blood loss after delivery of the fetus
1 secondary outcome
Duration of third stage of the labor
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 37698604Kadirogullari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active management of third stage of labor in people with Postpartum Hemorrhage, run by Kanuni Sultan Suleyman Training and Research Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum hemorrhage (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858569, which also lists 1 linked publication.
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 9 Jan 2024.