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

Study Overview
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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.

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

Conditions
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Vitamin K

Intervention / Treatment
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* Dietary Supplement: vitamin k


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 20-40 years. Gestational age between 36-39 weeks. Patients who will undergo an elective cesarean section. Full-term alive baby. Non-scarred uterus. No obstetric or medical complications. No bleeding tendency. Exclusion Criteria: Patients at less than 36 gestational weeks. Patient refusal. Patients who have thrombo-embolic complications. Patients with obstetric and medical complications. Patients with anomalous fetuses. Patients on anti-coagulant drugs, long-term antibiotics, and anti-epileptic drugs. Patients with obstetric cholestasis. Patients with a previous history of preterm labor. Patients with multiple pregnancies. Gestational hypertension or preeclampsia. Blood clotting disorders. Placental abnormalities such as, Placenta accreta, Placenta increta, and Placenta percreta. Placental abruption and Placenta previa.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |