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Completed

NCT Number: NCT05759156

Tranexamic Acid in Patients for Caesarian Delivery.

This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DowUHS

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

The inclusion criteria will include:

  • Informed consent of the participant
  • All women who are 18 years old or above
  • Gestational age equal or above 34 weeks
  • Women undergoing emergency or elective CD
  • Complete blood count (CBC) within seven days before the CD

Exclusion criteria

The exclusion criteria will include:

  • Women with thromboembolic or bleeding incidents in the past
  • Hypersensitivity to TXA
  • History of epilepsy or seizure
  • Women with abnormal placenta including accreta, increta or percreta
  • Any active cardiovascular, renal, or liver disorders
  • Autoimmune disorders
  • Sickle cell disease
  • Placenta Previa
  • Abruptio Placentae
  • Eclampsia or HELLP syndrome
  • Women who might undergo intraoperative complications.

Treatment and study plan

Tranexamic acid injection

Drug

The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.

Primary outcomes

  1. Occurrence of postpartum haemorrhage (PPH)

    Time frame: up to 2 days

  2. Obstetrics quality of recovery (ObsQoR) score

    Time frame: at 2 days

Secondary outcomes

  1. Measurement of postpartum blood loss

    Time frame: at 2 days

  2. Operative time

    Time frame: up to 3 hours

  3. Length of hospital stay

    Time frame: up to 4 days

  4. Frequency of emergency surgery for postpartum haemorrhage

    Time frame: up to 12 hours

  5. Rate of ICU transfer

    Time frame: up to 1 day

  6. Rate of Maternal death

    Time frame: up to 3 months

  7. Adverse events related to tranexamic acid

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).

Acronym: TXA; CD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
Registry last updated
Feb 4, 2025

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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