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

Not Applicable

Completed

• Conditions: Vitamin K
• Interventions: Dietary Supplement: vitamin k

• Registration Number: NCT04984083
• Lead Sponsor: National Research Centre, Egypt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-24
• Study Start: 2021-07-30
• Study First Posted: 2021-07-30
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-12
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Research Centre; 🇪🇬 Cairo, Egypt