Cesarean Section ComplicationsNCT03967171
The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery
A study testing before uterine incision oxytocin and after clamping the umbilical cord oxytocin in people with Cesarean Section Complications and Postpartum Hemorrhage, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section 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
- Cesarean Section Complications, Postpartum Hemorrhage, Blood Loss, Surgical
- What is being tested?
- before uterine incision oxytocin and after clamping the umbilical cord oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Jul 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
- single fetus at term >37 weeks of gestational age
Who cannot join
- history of previous cesarean section
- history of previous uterine surgery
- multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
- women at high risk for uterine atony such as anemia (Hb < 8 gm/dL)
- uterine atony history
- gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University Hospital
Istanbul, 34093
About this study
Official title: The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery: a Randomised Controlled Trial
This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section
Read the detailed description
Postpartum hemorrhage (PPH) is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. The average blood loss during cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery. Worldwide, the most commonly used uterotonic for the prevention of PPH is oxytocin. Several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects. In the current study, we tested the hypothesis that initiating IV oxytocin infusion earlier before uterine incision would induce a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the same dose administered after delivery of the fetus.
- Conditions
- Cesarean Section Complications, Postpartum Hemorrhage, Blood Loss, Surgical, Blood Loss, Postoperative, Postoperative Pain, Atony, Uterine
- Being tested
- before uterine incision oxytocin, after clamping the umbilical cord oxytocin
- Keywords
- Oxytocin, cesarean section, uterine atony, Postpartum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage, Pain, Postoperative, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
before uterine incision oxytocinOther
blood loss during elective cesarean section
after clamping the umbilical cord oxytocinOther
blood loss during elective cesarean section
| Study group | Role | What they receive |
|---|---|---|
| before uterine incision oxytocin group | Experimental | IV infusion of 20 IU of oxytocin started before uterine incision Receives: Other: before uterine incision oxytocin |
| after clamping the umbilical cord oxytocin group | Active comparator | IV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord Receives: Other: after clamping the umbilical cord oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss during elective cesarean section
The intraoperative blood loss will be measured by adding the volume of the suction bottle with the blood soaked sponges (know dry weight). The blood loss was estimated after excluded amniotic fluid volume in the suction bottle in each case
Measured: 2 hours
Secondary outcomes (1)
postoperative blood loss
The hemoglobin and hematocrit values will be measured 24 hours after CS
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 May 2019
- Primary completion20 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967171
- Sponsor's protocol ID
- BezmialemVU Oxytocin effect
- Status last verified
- Sep 2019
- First submitted
- 27 May 2019
- Last updated
- 24 Sep 2019
- Results posted
- 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03967171
- Acronym / sponsor ID
- BezmialemVU Oxytocin effect
- Conditions
- Cesarean Section Complications, Postpartum Hemorrhage, Blood Loss, Surgical, Blood Loss, Postoperative, Postoperative Pain, Atony, Uterine
- Keywords
- Oxytocin, cesarean section, uterine atony, Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 30 May 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.
This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section
Detailed description
Postpartum hemorrhage (PPH) is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. The average blood loss during cesarean section is 1000 ml which is nearly double the blood loss during vaginal delivery. Worldwide, the most commonly used uterotonic for the prevention of PPH is oxytocin. Several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects. In the current study, we tested the hypothesis that initiating IV oxytocin infusion earlier before uterine incision would induce a rapid acceptable uterine contraction and minimize the intraoperative blood loss than the same dose administered after delivery of the fetus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before uterine incision oxytocin group | Experimental | Other: before uterine incision oxytocinIV infusion of 20 IU of oxytocin started before uterine incision |
| after clamping the umbilical cord oxytocin group | Active comparator | Other: after clamping the umbilical cord oxytocinIV infusion of 20 IU of oxytocin started immediately after clamping the umbilical cord |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- single fetus at term >37 weeks of gestational age
Key exclusion criteria (6 listed)
- history of previous cesarean section
- history of previous uterine surgery
- multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
- women at high risk for uterine atony such as anemia (Hb < 8 gm/dL)
- uterine atony history
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 |
|---|---|---|
| before uterine incision oxytocinblood loss during elective cesarean section | Other | before uterine incision oxytocin group |
| after clamping the umbilical cord oxytocinblood loss during elective cesarean section | Other | after clamping the umbilical cord oxytocin group |
Primary outcome
blood loss during elective cesarean section
Time frame: 2 hours
The intraoperative blood loss will be measured by adding the volume of the suction bottle with the blood soaked sponges (know dry weight). The blood loss was estimated after excluded amniotic fluid volume in the suction bottle in each case
1 secondary outcome
postoperative blood loss
Time frame: 24 hours
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 24 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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 before uterine incision oxytocin and after clamping the umbilical cord oxytocin in people with Cesarean Section Complications and Postpartum Hemorrhage, run by Bezmialem Vakif University 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 6 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 24 Sep 2019. 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?
blood loss during elective cesarean section (time frame: 2 hours). 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 24 Sep 2019.