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Completed

NCT Number: NCT04984083

Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section

Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in decreasing blood loss during and after elective cesarean section (CS), and to assess the neonatal beneficial effects of prophylactic maternal vitamin k administration.

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Key information

Conditions

Vitamin K

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age from 20-40 years.
  • Gestational age between 36-39 weeks.
  • Patients who will undergo an elective cesarean section.
  • Full-term alive baby.
  • Non-scarred uterus.
  • No obstetric or medical complications.
  • No bleeding tendency.

Exclusion criteria

  • Patients at less than 36 gestational weeks.
  • Patient refusal.
  • Patients who have thrombo-embolic complications.
  • Patients with obstetric and medical complications.
  • Patients with anomalous fetuses.
  • Patients on anti-coagulant drugs, long-term antibiotics, and anti-epileptic drugs.
  • Patients with obstetric cholestasis.
  • Patients with a previous history of preterm labor.
  • Patients with multiple pregnancies.
  • Gestational hypertension or preeclampsia.
  • Blood clotting disorders.
  • Placental abnormalities such as, Placenta accreta, Placenta increta, and Placenta percreta.
  • Placental abruption and Placenta previa.

Treatment and study plan

Vitamin K

Dietary Supplement

patients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section

Primary outcomes

  1. Blood loss (measured in cc)

    Time frame: During Cesarean Section

  2. Prothrombin time of the mother (measured in seconds)

    Time frame: 6 hour postmartum

  3. Activated Partial Thromboplastin Time (APTT) of the mother (measured in seconds)

    Time frame: 6 hour postmartum

  4. Prothrombin Concentration (PC) of the mother (measured in %)

    Time frame: 6 hour postmartum

  5. Prothrombin time of the newborn (measured in seconds)

    Time frame: immediately after birth

  6. Prothrombin Concentration (PC) of the newborn (measured in %)

    Time frame: immediately after birth

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Collaborators

  • Minia University

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2021
Registry last updated
Feb 15, 2022

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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