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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Vitamin K

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group I

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

Group Type EXPERIMENTAL

vitamin k

Intervention Type DIETARY_SUPPLEMENT

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

Group II

patients will not take vitamin k before cesarean section

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vitamin k

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes