Intraoperative Blood LossNCT06889155
Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery .
A study testing Oxytocin in people with Intraoperative Blood Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intraoperative Blood Loss
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2023to 14 Sep 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 40 years
- singleton full term pregnancy.
- Candidate for elective cesarean delivery under spinal anaesthesia
Who cannot join
- women at high risk for intraoperative bleeding as those with placenta previa or other placental abnormalities
- women with bleeding or coagulation disorders.
- Medical disorder associating pregnancy as preeclampsia or diabetes
- Allergy or contraindications to oxytocin
- Fetal macrosomia, or congenital anomalies
- Polyhydramnios
- Uterine abnormalities as fibroids
- Women with intraoperative complications as vascular or visceral injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery in Low Risk Women.
Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
Read the detailed description
Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
- Conditions
- Intraoperative Blood Loss
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| oxytocin before placental delivery | Active comparator | oxytocin infusion before placental delivery just after cord clamping 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes. Receives: Drug: Oxytocin |
| oxytocin after placental delivery | Active comparator | oxytocin infusion after placental delivery 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
This was measured by weighing the surgical sponges and the suction canisters used during the procedure
Measured: during cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start30 Aug 2023
- Primary completion27 May 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Blood LossStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889155
- Sponsor's protocol ID
- 110
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery in Low Risk Women.
- ClinicalTrials.gov ID
- NCT06889155
- Acronym / sponsor ID
- 110
- Conditions
- Intraoperative Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 21 Mar 2025 (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.
Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
Detailed description
Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin before placental delivery | Active comparator | Drug: Oxytocinoxytocin infusion before placental delivery just after cord clamping 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes. |
| oxytocin after placental delivery | Active comparator | Drug: Oxytocinoxytocin infusion after placental delivery 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 - 40 years
- singleton full term pregnancy.
- Candidate for elective cesarean delivery under spinal anaesthesia
Key exclusion criteria (8 listed)
- women at high risk for intraoperative bleeding as those with placenta previa or other placental abnormalities
- women with bleeding or coagulation disorders.
- Medical disorder associating pregnancy as preeclampsia or diabetes
- Allergy or contraindications to oxytocin
- Fetal macrosomia, or congenital anomalies
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 |
|---|---|---|
| Oxytocin10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes. | Drug | oxytocin after placental delivery, oxytocin before placental delivery |
Primary outcome
Intraoperative blood loss
Time frame: during cesarean delivery
This was measured by weighing the surgical sponges and the suction canisters used during the 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 21 Mar 2025.
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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.
Ahmed Maged, MD principal investigator
Cairo University
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 Intraoperative Blood Loss, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 8 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 21 Mar 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 Egypt. 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?
Intraoperative blood loss (time frame: during cesarean delivery). 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 21 Mar 2025.