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

National Research Centre, Egypt

Status: Completed

Conditions: Vitamin K

Treatments: Dietary Supplement: vitamin k

Study type: Interventional

Funder types: Other

Identifiers

NCT04984083

Prophylactic Vitamin K

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Dietary Supplement: vitamin k

Group II

No Intervention group

Description:

patients will not take vitamin k before cesarean section