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

Vitamin K Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984083
• Other study ID #: Prophylactic Vitamin K
• Status: Completed
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin K

Intervention

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

Locations

Country	Name	City	State
Egypt	National Research Centre	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
National Research Centre, Egypt	Faculty of Medicine, Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss (measured in cc)		During Cesarean Section
Primary	Prothrombin time of the mother (measured in seconds)		6 hour postmartum
Primary	Activated Partial Thromboplastin Time (APTT) of the mother (measured in seconds)		6 hour postmartum
Primary	Prothrombin Concentration (PC) of the mother (measured in %)		6 hour postmartum
Primary	Prothrombin time of the newborn (measured in seconds)		immediately after birth
Primary	Prothrombin Concentration (PC) of the newborn (measured in %)		immediately after birth