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Completed

NCT Number: NCT04201951

Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women

Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage High Risk Pregnancy Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Third-Stage Postpartum Hemorrhage, With Delivery Tranexamic Acid Urogenital Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kurdistan Board for Medical speciality, Erbil, Kurdistan Region, Iraq

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About this study

Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.

A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 year.
  • Planed vaginal delivery
  • Grand multiparity
  • Twin pregnancy
  • Polyhydramnios
  • Previous history of PPH
  • Macrosomic baby
  • Prolonged labour
  • HELLP syndrome
  • Using of low-molecular weight heparin and Asprin during pregnancy.
  • Vaginal birth after Cesarean section

Exclusion criteria

  • Intrauterine death.
  • History of thromboembolic disease
  • Current or previous history of heart disease ,renal and liver disorders
  • History of seizure or epilepsy
  • Placenta previa
  • Placental abruptio

Treatment and study plan

Tranexamic acid injection

Drug

Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Other names: TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India

Glucose water 5%

Other

Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Other names: Glucose B.Braun 50 mg/mL

Primary outcomes

  1. The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)

    Time frame: From the time of injection and up to 2 hours after delivery

    The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use)

Secondary outcomes

  1. Number of participant with Post Partum Hemorrhage

    Time frame: up to 2 hours after delivery

    Vaginal blood loss of more than 500 mL

  2. Number of participant with severe postpartum hemorrhage

    Time frame: up to 2 hours after delivery

    Vaginal blood loss ≥1000mL

  3. Number of participant who will need additional uterotonic drugs to control blood loss

    Time frame: up to 2 hours after delivery

    Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally

  4. the mean length of third stage of labor in both groups

    Time frame: up to 30 minutes

    time from injection of the intervention and placebo group till the delivery of placenta

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2019
Registry last updated
Dec 24, 2020

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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