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

February 12, 2022 updated by: Mazen Abdel Rasheed, National Research Centre, Egypt
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • National Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
patients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section
Dietary supplement: vitamin k
patients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section
No Intervention: Group II
patients will not take vitamin k before cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood loss (measured in cc)
Time Frame: During Cesarean Section
During Cesarean Section
Prothrombin time of the mother (measured in seconds)
Time Frame: 6 hour postmartum
6 hour postmartum
Activated Partial Thromboplastin Time (APTT) of the mother (measured in seconds)
Time Frame: 6 hour postmartum
6 hour postmartum
Prothrombin Concentration (PC) of the mother (measured in %)
Time Frame: 6 hour postmartum
6 hour postmartum
Prothrombin time of the newborn (measured in seconds)
Time Frame: immediately after birth
immediately after birth
Prothrombin Concentration (PC) of the newborn (measured in %)
Time Frame: immediately after birth
immediately after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre, Egypt

Collaborators

Faculty of Medicine, Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 24, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 12, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prophylactic Vitamin K

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin K

Clinical Trials on vitamin k

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe