Postpartum BleedingPhase 4NCT07566455
Comparing Intra-Umbilical Versus Intravenous Oxytocin in Women During the Third Stage of Labor for Reducing Blood Loss
A Phase 4 study testing Oxytocin after delivery and Intraumbilical oxytocin in people with Postpartum Bleeding and Oxytocin, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Bleeding, Oxytocin, Third Stage of Labour
- What is being tested?
- Oxytocin after delivery and Intraumbilical oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Aug 2025to 12 Feb 2026
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age 36 - 42 weeks (on LMP)
- In spontaneous labour
Who cannot join
- Chronic hypertension
- Pre-eclampsia
- Multiple pregnancies
- Preterm or postdates pregnancy
- Previous cesarean section
- Diabetes (chronic and gestational)
Show all 10Show fewer
- Fetal macrosomia
- History of bleeding / clotting disorder
- History of anti-coagulation heparin / warfarin therapy
- Non-reassuring cardiotocograph or poor progress of labour
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
CMH Multan Institute of Medical Sciences
Multan, Punjab Province, 60000
About this study
Official title: Comparing the Effect of Intra-Umbilical Versus Intravenous Oxytocin During Third Stage of Labor on Mean Blood Loss
The goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Excessive bleeding after delivery, known as postpartum hemorrhage, is a major cause of maternal illness and death worldwide. Oxytocin is commonly used to help the uterus contract and reduce bleeding after childbirth.
The main question this study aims to answer is:
Read more
Does intra-umbilical oxytocin reduce the average amount of blood loss during the third stage of labor compared with intravenous oxytocin?
Researchers will conduct a randomized controlled trial involving 60 women with uncomplicated pregnancies who are in spontaneous labor. Participants will be randomly assigned to one of two groups.
Participants in the first group will receive 10 IU oxytocin intravenously at the delivery of the baby's anterior shoulder. Participants in the second group will receive 10 IU oxytocin injected into the umbilical cord after the baby is delivered.
In both groups, the placenta will be delivered using controlled cord traction. Blood loss will be measured by collecting blood in a kidney tray and by weighing pre-weighed sanitary pads for the first 24 hours after delivery.
Researchers will compare the average blood loss between the two groups to determine which method of administering oxytocin is more effective in reducing postpartum bleeding.
- Conditions
- Postpartum Bleeding, Oxytocin, Third Stage of Labour
- Being tested
- Oxytocin after delivery, Intraumbilical oxytocin
- Keywords
- Intravenous oxytocin, intra umbilical oxytocin, postpartum hemorrhage, third stage of labour
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin after deliveryDrug
10 IU oxytocin diluted in normal saline administered slowly via intravenous route at the time of delivery of the anterior shoulder to facilitate uterine contraction and reduce blood loss.
Intraumbilical oxytocinDrug
10 IU oxytocin diluted in 10 mL normal saline injected into the umbilical vein approximately 2 cm from the introitus after delivery of the baby, with the solution gently milked toward the placental insertion to promote placental separation and reduce blood loss.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Oxytocin | Active comparator | Women in this group will receive 10 IU oxytocin administered intravenously at the delivery of the anterior shoulder of the baby during the third stage of labor. Receives: Drug: Oxytocin after delivery |
| Intraumbilical Oxytocin | Experimental | Women in this group will receive 10 IU oxytocin administered through the umbilical vein after delivery of the baby during the third stage of labor. Receives: Drug: Intraumbilical oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery
The average amount of blood lost after delivery will be measured in milliliters. Blood loss will be collected in a kidney tray immediately after delivery and quantified using a graduated cylinder. Additional blood loss during the first 24 hours postpartum will be measured using pre-weighed sanitary pads (1 gram weight increase = 1 mL blood loss).
Measured: From delivery of the baby until 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start13 Aug 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum BleedingStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Multan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Sana Siddique, CMH Multan Institute of Medical Sciences
- Investigators
- Nidda Y Assistant Professor, FCPS, Study chair, CMH Multan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566455
- Sponsor's protocol ID
- U1111-1339-8043
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Intra-Umbilical Versus Intravenous Oxytocin During Third Stage of Labor on Mean Blood Loss
- ClinicalTrials.gov ID
- NCT07566455
- Acronym / sponsor ID
- U1111-1339-8043
- Conditions
- Postpartum Bleeding, Oxytocin, Third Stage of Labour
- Keywords
- Intravenous oxytocin, intra umbilical oxytocin, postpartum hemorrhage, third stage of labour
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CMH Multan Institute of Medical SciencesOther government
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 5 May 2026 (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 goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Excessive bleeding after delivery, known as postpartum hemorrhage, is a major cause of maternal illness and death worldwide. Oxytocin is commonly used to help the uterus contract and reduce bleeding after childbirth.
The main question this study aims to answer is:
Does intra-umbilical oxytocin reduce the average amount of blood loss during the third stage of labor compared with intravenous oxytocin?
Researchers will conduct a randomized controlled trial involving 60 women with uncomplicated pregnancies who are in spontaneous labor. Participants will be randomly assigned to one of two groups.
Participants in the first group will receive 10 IU oxytocin intravenously at the delivery of the baby's anterior shoulder. Participants in the second group will receive 10 IU oxytocin injected into the umbilical cord after the baby is delivered.
In both groups, the placenta will be delivered using controlled cord traction. Blood loss will be measured by collecting blood in a kidney tray and by weighing pre-weighed sanitary pads for the first 24 hours after delivery.
Researchers will compare the average blood loss between the two groups to determine which method of administering oxytocin is more effective in reducing postpartum bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Oxytocin | Active comparator | Drug: Oxytocin after deliveryWomen in this group will receive 10 IU oxytocin administered intravenously at the delivery of the anterior shoulder of the baby during the third stage of labor. |
| Intraumbilical Oxytocin | Experimental | Drug: Intraumbilical oxytocinWomen in this group will receive 10 IU oxytocin administered through the umbilical vein after delivery of the baby during the third stage of labor. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gestational age 36 - 42 weeks (on LMP)
- In spontaneous labour
Key exclusion criteria (10 listed)
- Chronic hypertension
- Pre-eclampsia
- Multiple pregnancies
- Preterm or postdates pregnancy
- Previous cesarean section
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 |
|---|---|---|
| Oxytocin after delivery10 IU oxytocin diluted in normal saline administered slowly via intravenous route at the time of delivery of the anterior shoulder to facilitate uterine contraction and reduce blood loss. | Drug | Intravenous Oxytocin |
| Intraumbilical oxytocin10 IU oxytocin diluted in 10 mL normal saline injected into the umbilical vein approximately 2 cm from the introitus after delivery of the baby, with the solution gently milked toward the placental insertion to promote placental separation and reduce blood loss. | Drug | Intraumbilical Oxytocin |
Primary outcome
Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery
Time frame: From delivery of the baby until 24 hours postpartum
The average amount of blood lost after delivery will be measured in milliliters. Blood loss will be collected in a kidney tray immediately after delivery and quantified using a graduated cylinder. Additional blood loss during the first 24 hours postpartum will be measured using pre-weighed sanitary pads (1 gram weight increase = 1 mL blood loss).
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 5 May 2026.
- Individual participant dataSharing planned: No
Related trials for Postpartum Bleeding
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Nidda Y Assistant Professor, FCPS study chair
CMH Multan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin after delivery and Intraumbilical oxytocin in people with Postpartum Bleeding and Oxytocin, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
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 2 inclusion and 10 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 5 May 2026. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery (time frame: From delivery of the baby until 24 hours postpartum). 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 5 May 2026.