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Cesarean Section ComplicationsNCT04313218

Carbetocin Versus Misoprostol. A Retrospective Comparative Study

An observational study of Cesarean Section Complications, run by Port Said University hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cesarean section is one of the most common surgeries practiced for save delivery of the fetus, however it is not a safe route of delivery its incidence is rising especially in high and middle income countries. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Section Complications
What is being tested?
Carbetocin
Type of treatment
Injection or infusion
How many people
300 participants
Where
1 siteEgypt
Study dates
1 Jan 2018to 28 Feb 2020
Phase
Observational
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: women who underwent CS and were considered at low risk for postpartum including 1- singleton pregnancy, 2- less than previous four deliveries, 3- elective lower segment C.S, 4- C.S was done under general anesthesia 5- No medical disorders complicating pregnancy, 6- Placenta neither previa nor morbidly adherent, 7- Average amount of amniotic fluid, 8- No past history of postpartum hemorrhage and 9- No contraindications to Misopristol or Carbetocin

Who may be able to join

  • parity less than 4
  • unscarred uterus or previous one cesarean section
  • elective C.S
  • general anesthesia

Who cannot join

  • medical disorders complicating pregnancy
  • more than one C.S
  • selective C.S
  • Risk factors for Postpartum hemorrhage

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Waleed Elsayed Elrefaie

    Port Said, NY, 42511

Other trials in Egypt

About this study

Official title: Carbetocin Versus Misoprostol in Reducing Blood Loss During Cesarean Section in Low Risk Patients. A Retrospective Comparative Study

Cesarean section is one of the most common surgeries practiced for save delivery of the fetus, however it is not a safe route of delivery its incidence is rising especially in high and middle income countries. The major concern is that the average blood loss during cesarean delivery is 487 ml, this amount is too close to the definition of postpartum hemorrhage by WHO as loss of 500 cc of blood in the first 24 hours after delivery making control of blood loss during cesarean delivery crucial to decrease maternal morbidities.This study aim to compare the use of misoprostol to carbetocin in reducing blood loss during cesarean section in low risk patients

Read the detailed description

Cesarean section is one of the most common surgeries practiced for save delivery of the fetus, however it is not a safe route of delivery its incidence is rising especially in high and middle income countries. Although the WHO recommended cesarean section rate between 10 to 15% to decline the maternal mortality ratio and Neonatal mortality ratio, the incidence show sharp increase especially in Egypt to reach 52% of all deliveries. The major concern is that the average blood loss during cesarean delivery is 487 ml, this amount is too close to the definition of postpartum hemorrhage by WHO as loss of 500 cc of blood in the first 24 hours after delivery making control of blood loss during cesarean delivery crucial to decrease maternal morbidities. Many medications used to decrease blood loss especially placental site bleeding during cesarean section including oxytocin, ergometrine, synthetic prostaglandins and recently carbetocin.

Carbetocin is an oxytocin analogue containing eight amino acids .It binds to oxytocin receptors expressed on uterine muscles of pregnant women inducing tetanic uterine contractions for about 11 minutes after administration of 8-30ug intravenous followed by rhythmic uterine contractions that last for 60 to 120 minutes. Also it has a longer half life time than oxytocin and the recommended dose is 100ug IV.

Misoprostol is synthetic analogue to prostaglandin which is cheap heat stable uterotonic making it the alternative of choice to intravenous oxytocin in low resources countries. The recommended dose for prophylaxis against postpartum hemorrhage is 600μg while 800μg is used as a treatment.

In the lack of sufficient studies comparing the use of carbetocin to misoprostol to decrease blood loss during cesarean section we perform this study to compare the use of misoprostol to carbetocin in reducing blood loss during cesarean section.

Patients and Methods This was a retrospective comparative study conducted in Port Said General Hospital And Private practice in Port Said Egypt. Following approval of the study protocol by the ethical committee in Faculty of medicine Port Said University. The medical records of patients in the period from January 2018 to February 2019 were searched; women who underwent CS and were considered at low risk for postpartum including 1- singleton pregnancy, 2- less than previous four deliveries, 3- elective lower segment C.S, 4- C.S was done under general anesthesia 5- No medical disorders complicating pregnancy, 6- Placenta neither previa nor morbidly adherent, 7- Average amount of amniotic fluid, 8- No past history of postpartum hemorrhage and 9- No contraindications to Misopristol or Carbetocin 300 patients were eligible and were enrolled in this study. Women who received Carbetocin 100ug i.v (PABAL 100 micrograms/ml solution for injection, Ferring Pharmaceuticals Ltd) intra operative immediately after extraction of the fetus, were enrolled into group A and women who received misoprostol 600ug (cytotec 200ug tablet, Pfizer G.D. Searle LLC) rectally immediately before sterilization during caesarean section were enrolled into group B.

Maternal data (demographic and clinical), ultrasound findings, operative details, and postoperative characteristics were recorded in a database. The outcome measures of this study were the need for blood products transfusion, the amount of blood products transfusion, the operative time, operative complications uterine atony the need for surgical interventions to stop bleeding as uterine artery ligation and uterine compression sutures and the deficit in hemoglobin level.

Being tested
Carbetocin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarbetocinDrug

    Also called misoprostol

    iv infusion of 100ug carbetocin after extraction of the fetus during cesarean section

Study groups in NCT04313218
Study groupRoleWhat they receive
Arecieved carbetocin 100ug iv after immediately after extraction of the fetus during cesarean section
Receives: Drug: Carbetocin
Bwomen who received misoprostol 600ug rectally immediately before sterilization during cesarean section

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood loss

    reduction of blood loss during cesarean section operation

    Measured: during operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2020
  2. Study start1 Jan 2018
  3. Primary completion1 Feb 2020
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313218
Sponsor's protocol ID
OBSGYN 1
Status last verified
Mar 2020
First submitted
15 Mar 2020
Last updated
18 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Section Complications, run by Port Said University 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 4 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 18 Mar 2020. 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?

blood loss (time frame: during operation). 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 18 Mar 2020.

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