Postpartum HemorrhagePhase 2NCT03006380
Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery
A Phase 2 study testing oxytocin in people with Postpartum Hemorrhage, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery. 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
- 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
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to Sep 2017
- Phase
- Phase 2
- 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
- Multiparous women (had previous one, up to four deliveries)
- Term pregnancy (37 completed weeks at least).
- Singleton viable cephalic pregnancy.
- Vaginal delivery.
Who cannot join
- Primigravida.(first pregnancy)
- Grand multiparous. (had previous 5 or more deliveries)
- Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems)
- Previous cesarean section, uterine surgery.
- Patients with bleeding tendency.
- Previous history of Ante-partum hemorrhage.
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- Previous history of postpartum hemorrhage.
- Abnormal site of the placenta (detected by ultrasound)
- Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound)
- polyhydramnios.(detected by ultrasound)
- Multiple gestation.
- Chorioamnionitis.
- Suspected fetal problem(anomaly, distress)
- Instrumental delivery.
- Multiple or deep vaginal tears that compromise the estimation of uterine blood loss.
- Cesarean delivery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo
Amr Yehia, MD
About this study
Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.
Read the detailed description
400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients.
The recruited patients will be subjected to the following:
- History taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history.
- Checking vital signs, General and abdominal examination.
- laboratory investigations: complete blood count (CBC)
- Findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram.
- All deliveries will be attended by a senior resident in the hospital.
- Included patients will receive the medication according to randomization tables.
- After allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss.
- All patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord.
- All patients will undergo cord clamping and cutting within 30 seconds of delivery.
- All patients will undergo uterine massage for 30 seconds after placental delivery.
- Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery.
- CBC will be collected 6 hours after delivery.
- Conditions
- Postpartum Hemorrhage
- Being tested
- oxytocin
- 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
Also called Syntocinon®, NOVARTIS, Egypt
Ecbolic used to reduce blood loss
| Study group | Role | What they receive |
|---|---|---|
| oxytocin before placental delivery | Experimental | patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta. Receives: Drug: oxytocin |
| oxytocin after placental delivery | Experimental | patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence) Receives: Drug: oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss in vaginal delivery
Measured: blood loss in the third stage of labor (Up to 60 min after delivery of the baby)
Secondary outcomes (10)
primary postpartum hemorrhage
Measured: within 24 hours after delivery
changes in hemoglobin and hematocrit
Measured: before delivery and after 6 hours
retained placenta
Measured: more than 30 minutes after delivery
length of 3rd stage of labor
Measured: Up to 60 min from delivery of baby till delivery of placenta
manual removal of the placenta
Measured: if not separated after 30 minutes from delivery
blood pressure
Measured: to be measured before delivery after 15 minutes,1 hour,6 hours
maternal pain
Measured: during third stage of labor
maternal nausea and vomiting
Measured: during 3rd stage of labor
secondary postpartum hemorrhage
Measured: after 24 hours and before 6 weeks from delivery
surgical intervention to stop the bleeding
Measured: within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMR HELMY YEHIA, Ain Shams Maternity Hospital
- Investigators
- Amr Yehia, MD, MRCOG, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006380
- Sponsor's protocol ID
- oxytocin
- Status last verified
- Mar 2017
- First submitted
- 22 Dec 2016
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery
- ClinicalTrials.gov ID
- NCT03006380
- Acronym / sponsor ID
- oxytocin
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 Dec 2016 (estimated)
- 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.
Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.
Detailed description
400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients.
The recruited patients will be subjected to the following:
- History taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history.
- Checking vital signs, General and abdominal examination.
- laboratory investigations: complete blood count (CBC)
- Findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram.
- All deliveries will be attended by a senior resident in the hospital.
- Included patients will receive the medication according to randomization tables.
- After allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss.
- All patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord.
- All patients will undergo cord clamping and cutting within 30 seconds of delivery.
- All patients will undergo uterine massage for 30 seconds after placental delivery.
- Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery.
- CBC will be collected 6 hours after delivery.
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 | Experimental | Drug: oxytocinpatients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta. |
| oxytocin after placental delivery | Experimental | Drug: oxytocinpatients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Multiparous women (had previous one, up to four deliveries)
- Term pregnancy (37 completed weeks at least).
- Singleton viable cephalic pregnancy.
- Vaginal delivery.
Key exclusion criteria (16 listed)
- Primigravida.(first pregnancy)
- Grand multiparous. (had previous 5 or more deliveries)
- Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems)
- Previous cesarean section, uterine surgery.
- Patients with bleeding tendency.
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 |
|---|---|---|
| oxytocinAlso: Syntocinon®, NOVARTIS, EgyptEcbolic used to reduce blood loss | Drug | oxytocin after placental delivery, oxytocin before placental delivery |
Primary outcome
blood loss in vaginal delivery
Time frame: blood loss in the third stage of labor (Up to 60 min after delivery of the baby)
10 secondary outcomes
primary postpartum hemorrhage
Time frame: within 24 hours after delivery
changes in hemoglobin and hematocrit
Time frame: before delivery and after 6 hours
retained placenta
Time frame: more than 30 minutes after delivery
length of 3rd stage of labor
Time frame: Up to 60 min from delivery of baby till delivery of placenta
manual removal of the placenta
Time frame: if not separated after 30 minutes from delivery
blood pressure
Time frame: to be measured before delivery after 15 minutes,1 hour,6 hours
maternal pain
Time frame: during third stage of labor
maternal nausea and vomiting
Time frame: during 3rd stage of labor
secondary postpartum hemorrhage
Time frame: after 24 hours and before 6 weeks from delivery
surgical intervention to stop the bleeding
Time frame: within 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Amr Yehia, MD, MRCOG study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxytocin in people with Postpartum Hemorrhage, run by Ain Shams Maternity Hospital 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Mar 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Marie, MRCOG (+201212977339, rehamfarghal84@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss in vaginal delivery (time frame: blood loss in the third stage of labor (Up to 60 min after delivery of the baby)). 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 15 Mar 2017.