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

NCT04984083 | Completed

• 1 other identifier: Prophylactic Vitamin K
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin K

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

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

Group II

NO INTERVENTION

patients will not take vitamin k before cesarean section

Interventions

vitamin k 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 I

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• Faculty of Medicine, Minia University: collaborator

Study Sites (1)

National Research Centre

Cairo, Egypt

Location

MeSH Terms

Interventions

Vitamin K

Intervention Hierarchy (Ancestors)

Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 30, 2021
• Study Start: July 30, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

EG (1)