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Completed

NCT Number: NCT03870503

Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University Hospital

Aswān, 81528, Egypt

About this study

The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.

Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation

Exclusion criteria

  • gestational age<37 weeks,
  • genital tract trauma,
  • coagulation defect,
  • women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
  • known hypersensitivity to carbetocin or oxytocin.

Treatment and study plan

Oxytocin

Drug

The patient will be received oxytocin 20 IU by intravenous infusion

Other names: Active comparator

oxytocin plus misoprostol

Drug

The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol

Other names: Active Comparator

Carbetocin

Drug

The patient received Carbetocin 100 mic gm

Other names: Active Comparator

Primary outcomes

  1. The amount of blood loss

    Time frame: 6 hours post delivery

    calculation of the amount of blood loss by weighing the swabs and using pictorial charts

Secondary outcomes

  1. The number of patients develop blood loss more than 1000 ml

    Time frame: 24 hours post delivery

    Calculation of the number of patients develop blood loss more than 1000 ml

  2. The number of patient need blood transfusion

    Time frame: 24 hours post delivery

    Calculation of number of patient need blood transfusion

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2019
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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