Postpartum Hemorrhage (PPH)NCT07436286
Intra-Umbilical Vein Oxytocin Injection as an Adjunct to Active Management of the Third Stage of Labour
A study testing Oxytocin in people with Postpartum Hemorrhage (PPH) and Postpartum Hemorrhage Third Stage of Labour Retained Placenta, run by Dangana Zakari Adeka at 1 site in Nigeria.
Trial summary
This randomized controlled clinical trial evaluates the effect of umbilical vein injection of oxytocin given in addition to routine active management of the third stage of labour. 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 (PPH), Postpartum Hemorrhage Third Stage of Labour Retained Placenta
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Feb 2018to 31 Aug 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18 to 35 years Singleton live pregnancy Gestational age between 37 and 42 weeks Vaginal delivery Parity between 1 and 4 Haemoglobin concentration of 10 g/dl or higher before delivery No identifiable risk factors for postpartum haemorrhage Willing and able to provide written informed consent
Who cannot join
- Blood pressure ≥140/90 mmHg Placenta previa Placental abruption History of vaginal bleeding in the index pregnancy Previous caesarean section or any uterine scar Coagulation disorders Instrumental delivery Haemoglobin concentration below 10 g/dl Multiple gestation Fibroids coexisting with pregnancy Genital tract lacerations or bleeding episiotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria
This randomized controlled clinical trial evaluates the effect of umbilical vein injection of oxytocin given in addition to routine active management of the third stage of labour. The third stage of labour is associated with a risk of postpartum haemorrhage, a major cause of maternal morbidity and mortality, particularly in low-resource settings. Active management with intramuscular oxytocin and controlled cord traction is standard practice, but additional measures that can further reduce blood loss may improve maternal outcomes.
Eligible women undergoing vaginal delivery were randomly assigned to receive either an intra-umbilical injection of oxytocin diluted in normal saline or a placebo injection of normal saline, alongside standard active management of the third stage. The main outcomes assessed were postpartum blood loss, duration of the third stage of labour, and change in maternal haemoglobin concentration within 24 hours after delivery.
The study aims to determine whether local administration of oxytocin through the umbilical vein can enhance uterine contraction, promote placental separation, shorten the third stage of labour, and reduce postpartum blood loss compared with standard care alone.
Read the detailed description
Postpartum haemorrhage remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low-resource settings. A large proportion of these deaths occur during the third stage of labour, the period between delivery of the baby and expulsion of the placenta. Failure of effective uterine contraction and delayed placental separation during this stage can lead to excessive blood loss and significant reduction in maternal haemoglobin levels. Although active management of the third stage of labour with uterotonic agents and controlled cord traction is widely practiced and has been shown to reduce blood loss, additional low-cost and practical interventions that can further improve outcomes are still needed.
Oxytocin is a uterotonic drug that promotes uterine contraction and facilitates placental separation. Administering oxytocin through the umbilical vein allows the drug to reach the placental bed directly, which may enhance localized uterine contraction at the site of placental attachment. This targeted approach has the potential to shorten the duration of the third stage of labour, reduce the volume of postpartum blood loss, and help preserve maternal haemoglobin. Such an intervention may be particularly valuable in environments where access to blood transfusion and advanced obstetric care is limited, and where even moderate blood loss can result in serious complications.
This study was conducted to examine whether the addition of intra-umbilical oxytocin to standard active management provides measurable clinical benefit. By comparing outcomes between women who received oxytocin through the umbilical vein and those who received a placebo alongside routine care, the study seeks to contribute evidence on the effectiveness of this simple and inexpensive technique in improving maternal outcomes during the immediate postpartum period. The findings are intended to inform clinical practice and support strategies aimed at reducing preventable maternal complications associated with childbirth.
- Conditions
- Postpartum Hemorrhage (PPH), Postpartum Hemorrhage Third Stage of Labour Retained Placenta
- Being tested
- Oxytocin, Normal Saline (Placebo)
- Keywords
- 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.
OxytocinDrug
A single dose of 20 international units of oxytocin diluted in 18 ml of normal saline to a total volume of 20 ml was administered via intra-umbilical vein injection immediately after delivery of the baby and cord clamping. The injection was given slowly over approximately 30 seconds into the umbilical vein at a point 2-3 cm from the introitus using an 18-gauge needle. This was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction.
Normal Saline (Placebo)Other
A volume of 20 ml of plain normal saline was administered via intra-umbilical vein injection immediately after delivery of the baby and cord clamping. The injection was identical in volume and route of administration to the oxytocin intervention but contained no active drug. This served as the placebo comparator. It was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin group | Active comparator | Participants in this group received an intra-umbilical vein injection of 20 international units of oxytocin diluted in 18 ml of normal saline (total volume 20 ml) immediately after delivery of the baby and cord clamping. The injection was given slowly over 30 seconds into the umbilical vein. This was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin (10 IU) and controlled cord traction. Receives: Drug: Oxytocin |
| Normal Saline Group | Placebo comparator | Participants in this arm received an intra-umbilical vein injection of 20 ml of plain normal saline immediately after delivery of the baby and cord clamping. This was given in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction. The saline injection served as a placebo comparator to the oxytocin intervention. Receives: Other: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Blood Loss Measured by Calibrated Drape Weight Difference
Total volume of blood lost during the third stage of labour and within the first hour postpartum, collected using a Nightingale drape placed under the parturient immediately after delivery. The drape was weighed before and after use, and the difference in weight in grams was taken as equivalent to blood loss in millilitres.
Measured: Within 1 hour after delivery of the baby
Duration of the Third Stage of Labour Measured by Stopwatch
Time in minutes from delivery of the baby to complete expulsion of the placenta, measured using a stopwatch started immediately after birth of the baby and stopped at placental delivery.
Measured: From delivery of the baby to 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.
- First posted27 Feb 2026
- Study start1 Feb 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 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 Hemorrhage (PPH)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned into two parallel groups. One group received intra-umbilical vein injection of oxytocin in addition to routine active management of the third stage of labour, while the other group received a placebo injection of normal saline alongside the same standard management. Outcomes were compared between the two groups following delivery.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dangana Zakari Adeka
- Sponsor type
- University, hospital or other
- Collaborators
- West African College of Surgeons
- Responsible party
- Sponsor-investigator, Dangana Zakari Adeka, Ahmadu Bello University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436286
- Sponsor's protocol ID
- OXYRCT
- Other IDs
- ABUTHZ/HREC/C08/2017
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains confidential patient information collected as part of routine clinical care. There is no formal data sharing agreement or repository established for this study. Access to the data is restricted to the research team in order to protect participant privacy and maintain confidentiality in accordance with institutional and ethical requirements.
Publications
Dangana ZA. Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria. WACS Part II Dissertation, Faculty of Obstetrics and Gynaecology, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria
- ClinicalTrials.gov ID
- NCT07436286
- Acronym / sponsor ID
- OXYRCT
- Conditions
- Postpartum Hemorrhage (PPH), Postpartum Hemorrhage Third Stage of Labour Retained Placenta
- Keywords
- Postpartum Hemorrhage Third Stage of Labour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Dangana Zakari AdekaUniversity, hospital or other
- Collaborators
- West African College of Surgeons
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 27 Feb 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.
This randomized controlled clinical trial evaluates the effect of umbilical vein injection of oxytocin given in addition to routine active management of the third stage of labour. The third stage of labour is associated with a risk of postpartum haemorrhage, a major cause of maternal morbidity and mortality, particularly in low-resource settings. Active management with intramuscular oxytocin and controlled cord traction is standard practice, but additional measures that can further reduce blood loss may improve maternal outcomes.
Eligible women undergoing vaginal delivery were randomly assigned to receive either an intra-umbilical injection of oxytocin diluted in normal saline or a placebo injection of normal saline, alongside standard active management of the third stage. The main outcomes assessed were postpartum blood loss, duration of the third stage of labour, and change in maternal haemoglobin concentration within 24 hours after delivery.
The study aims to determine whether local administration of oxytocin through the umbilical vein can enhance uterine contraction, promote placental separation, shorten the third stage of labour, and reduce postpartum blood loss compared with standard care alone.
Detailed description
Postpartum haemorrhage remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low-resource settings. A large proportion of these deaths occur during the third stage of labour, the period between delivery of the baby and expulsion of the placenta. Failure of effective uterine contraction and delayed placental separation during this stage can lead to excessive blood loss and significant reduction in maternal haemoglobin levels. Although active management of the third stage of labour with uterotonic agents and controlled cord traction is widely practiced and has been shown to reduce blood loss, additional low-cost and practical interventions that can further improve outcomes are still needed.
Oxytocin is a uterotonic drug that promotes uterine contraction and facilitates placental separation. Administering oxytocin through the umbilical vein allows the drug to reach the placental bed directly, which may enhance localized uterine contraction at the site of placental attachment. This targeted approach has the potential to shorten the duration of the third stage of labour, reduce the volume of postpartum blood loss, and help preserve maternal haemoglobin. Such an intervention may be particularly valuable in environments where access to blood transfusion and advanced obstetric care is limited, and where even moderate blood loss can result in serious complications.
This study was conducted to examine whether the addition of intra-umbilical oxytocin to standard active management provides measurable clinical benefit. By comparing outcomes between women who received oxytocin through the umbilical vein and those who received a placebo alongside routine care, the study seeks to contribute evidence on the effectiveness of this simple and inexpensive technique in improving maternal outcomes during the immediate postpartum period. The findings are intended to inform clinical practice and support strategies aimed at reducing preventable maternal complications associated with childbirth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned into two parallel groups. One group received intra-umbilical vein injection of oxytocin in addition to routine active management of the third stage of labour, while the other group received a placebo injection of normal saline alongside the same standard management. Outcomes were compared between the two groups following delivery.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin group | Active comparator | Drug: OxytocinParticipants in this group received an intra-umbilical vein injection of 20 international units of oxytocin diluted in 18 ml of normal saline (total volume 20 ml) immediately after delivery of the baby and cord clamping. The injection was given slowly over 30 seconds into the umbilical vein. This was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin (10 IU) and controlled cord traction. |
| Normal Saline Group | Placebo comparator | Other: Normal Saline (Placebo)Participants in this arm received an intra-umbilical vein injection of 20 ml of plain normal saline immediately after delivery of the baby and cord clamping. This was given in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction. The saline injection served as a placebo comparator to the oxytocin intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women aged 18 to 35 years Singleton live pregnancy Gestational age between 37 and 42 weeks Vaginal delivery Parity between 1 and 4 Haemoglobin concentration of 10 g/dl or higher before delivery No identifiable risk factors for postpartum haemorrhage Willing and able to provide written informed consent
Key exclusion criteria (1 listed)
- Blood pressure ≥140/90 mmHg Placenta previa Placental abruption History of vaginal bleeding in the index pregnancy Previous caesarean section or any uterine scar Coagulation disorders Instrumental delivery Haemoglobin concentration below 10 g/dl Multiple gestation Fibroids coexisting with pregnancy Genital tract lacerations or bleeding episiotomy
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 |
|---|---|---|
| OxytocinA single dose of 20 international units of oxytocin diluted in 18 ml of normal saline to a total volume of 20 ml was administered via intra-umbilical vein injection immediately after delivery of the baby and cord clamping. The injection was given slowly over approximately 30 seconds into the umbilical vein at a point 2-3 cm from the introitus using an 18-gauge needle. This was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction. | Drug | Oxytocin group |
| Normal Saline (Placebo)A volume of 20 ml of plain normal saline was administered via intra-umbilical vein injection immediately after delivery of the baby and cord clamping. The injection was identical in volume and route of administration to the oxytocin intervention but contained no active drug. This served as the placebo comparator. It was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction. | Other | Normal Saline Group |
Primary outcome
Postpartum Blood Loss Measured by Calibrated Drape Weight Difference
Time frame: Within 1 hour after delivery of the baby
Total volume of blood lost during the third stage of labour and within the first hour postpartum, collected using a Nightingale drape placed under the parturient immediately after delivery. The drape was weighed before and after use, and the difference in weight in grams was taken as equivalent to blood loss in millilitres.
Duration of the Third Stage of Labour Measured by Stopwatch
Time frame: From delivery of the baby to delivery of the placenta
Time in minutes from delivery of the baby to complete expulsion of the placenta, measured using a stopwatch started immediately after birth of the baby and stopped at placental delivery.
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 27 Feb 2026.
- BackgroundDangana ZA. Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria. WACS Part II Dissertation, Faculty of Obstetrics and Gynaecology, 2016.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains confidential patient information collected as part of routine clinical care. There is no formal data sharing agreement or repository established for this study. Access to the data is restricted to the research team in order to protect participant privacy and maintain confidentiality in accordance with institutional and ethical requirements.
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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 Oxytocin in people with Postpartum Hemorrhage (PPH) and Postpartum Hemorrhage Third Stage of Labour Retained Placenta, run by Dangana Zakari Adeka at 1 site in Nigeria.
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 27 Feb 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 Nigeria. 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. Some participants in this study may receive a placebo. 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 Blood Loss Measured by Calibrated Drape Weight Difference (time frame: Within 1 hour after delivery of the baby). The study lists 2 primary outcomes in all. 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 NCT07436286, 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 27 Feb 2026.