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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04984083

Enrollment

200

Registered

2021-07-30

Start date

2021-07-30

Completion date

2021-12-31

Last updated

2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin K

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.

Interventions

DIETARY_SUPPLEMENTvitamin k

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026