Current partner codePEPTIDESDE
NCT05742854·Phase 4·INTERVENTIONAL

Comparison Of The Effects Of Carbetocin And Oxytocin In C-Sectıon

Status

Unknown

Phase

Phase 4

Enrollment

200

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Obstetric hemorrhage is the most common cause of maternal mortality worldwide and its incidence is estimated to be approximately 24%. A series of studies has shown that the risk of serious postpartum hemorrhage decreases with correct and active management in the third stage of labor. And the routine use of uterotonic agents underlies effective management. It has been reported that the routine use of uterotonic agents (oxytocin, carbetocin, ergometrine, etc.) reduces the risk of postpartum bleeding by 40% on average. However, the uterotonic agent and dose protocol are still unclear. Oxytocin is the most preferred agent for postpartum hemorrhage prophylaxis after vaginal and cesarean delivery in cases without risk factors, as it has a rapid onset of effect, does not increase blood pressure, and does not cause a retained placenta. In cases where oxytocin cannot be used, other agents of choice are ergot derivatives and misoprostol. The use of carbetocin, a long-acting oxytocin analogue, is now recommended in the guidelines for risky vaginal deliveries and postpartum hemorrhage prophylaxis after C-section. Carbetocin also reduces the need for additional uterotonics. Although carbetocin has been approved for use by the ministry of health, it still has limited clinical use in Turkey. It is vital for the medical community to have more experience with using carbetocin, an agent cited in medical guidelines and is also available in our country, and to share their experiences on academic platforms. This study intends to investigate oxytocin and carbetocin, which are uterotonic agents used during C-section, in terms of haemodynamic changes they cause, their effects on the uterine tone and on bleeding as well as their side effects (flushing, headache, back pain, hypertension and tachycardia, nausea-vomiting, etc.), to determine if there are any differences between them and share our insights with the reader.

Full detailed description

Obstetric hemorrhage is the most common cause of maternal mortality worldwide and its incidence is estimated to be approximately 24%. A series of studies has shown that the risk of serious postpartum hemorrhage decreases with correct and active management in the third stage of labor. And the routine use of uterotonic agents underlies effective management. It has been reported that the routine use of uterotonic agents (oxytocin, carbetocin, ergometrine, etc.) reduces the risk of postpartum bleeding by 40% on average. However, the uterotonic agent and dose protocol are still unclear. Oxytocin is the most preferred agent for postpartum hemorrhage prophylaxis after vaginal and cesarean delivery in cases without risk factors, as it has a rapid onset of effect, does not increase blood pressure, and does not cause a retained placenta. In cases where oxytocin cannot be used, other agents of choice are ergot derivatives and misoprostol. The use of carbetocin, a long-acting oxytocin analogue, is now recommended in the guidelines for risky vaginal deliveries and postpartum hemorrhage prophylaxis after C-section. Carbetocin also reduces the need for additional uterotonics. Although carbetocin has been approved for use by the ministry of health, it still has limited clinical use in Turkey. It is vital for the medical community to have more experience with using carbetocin, an agent cited in medical guidelines and is also available in our country, and to share their experiences on academic platforms. This study intends to investigate oxytocin and carbetocin, which are uterotonic agents used during C-section, in terms of haemodynamic changes they cause, their effects on the uterine tone and on bleeding as well as their side effects (flushing, headache, back pain, hypertension and tachycardia, nausea-vomiting, etc.), to determine if there are any differences between them and share our insights with the reader.

Interventions

Treatment arms and agents.

PROCEDURE

C-sections operations

Immediately after the delivery of the baby, uterotonic agents will be applied before the placenta is removed and by a manual check of the fundus of the uterus and the anterior wall, followed by an examination of the uterine tone by the surgeon

DRUG

Oxytocin

Oxytocin

DRUG

Carbetocin

Carbetocin

Timeline

From registration to results.

  1. First posted

    Feb 24, 2023

  2. Study start

    Mar 9, 2023

  3. Primary completion

    May 31, 2023

  4. Study completion

    Jun 21, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Mar 7, 2023

Outcomes

What the study measures.

Primary outcomes

Effect of uterotonic agents on uterine tone

Time frame · intraoperative

uterine tone (standardized as Very good, Good, Sufficient, Atony),

hemorrhage

Time frame · haemoglobin levels before and after 6 hours.

haemoglobin concentration

Secondary outcomes

in terms of haemodynamic changes uterotonic agents cause

Time frame · intraoperative time, after 30 minute

Blood pressure (in mmHg),hypotansion

side effects of uterotonic agents

Time frame · postoperative,24 hours after caesarean section

lushing, headache, back pain, hypertension and tachycardia, nausea-vomiting

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * 18-45 years old * Pregnant women to have a C-section, * Subjects with no history of oxytocin allergy, At term, no multiple pregnancies, elective C-section Exclusion Criteria: Subjects refusing to take part, * Subjects with a history of oxytocin allergy, Subjects scheduled for an emergency C-section, Multiple pregnancies, Having been diagnosed with diabetes mellitus

Study locations

1 registered sites.

Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.

EÜTF

Bornova, İ̇zmi̇r, Turkey (Türkiye)

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.