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Clinical trial

Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia : A Randomized Controlled Trial

ID
Name
2024-085-01
Description
This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-01-01
Trial end
2025-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Vitamin C Injection
Drug Specification: 5ml: 1g. Method: parturients in each group will be intravenously injected with corresponding dose after receiving epidural labor analgesia.
Arms:
Group C1, Group C2, Group C3
Other names:
Suicheng, H20046552
Normal saline
The placebo comparator will receive normal saline with the same volume and be administered after the induction of epidural labor anesthesia.
Arms:
Group P
Size
400
Primary endpoint
Intrapartum fever or not
Every two hours after receiving epidural labor analgesia, until baby delivery
The temperature of parturients
Every two hours after receiving epidural labor analgesia, until baby delivery.
The duration of intrapartum fever
Every two hours after receiving epidural labor analgesia, until baby delivery.
Complete blood count indicators
Take blood test immediately before analgesia, immediately when parturients is developing intrapartum fever and immediately after delivery
Eligibility criteria
Inclusion Criteria: * single-fetus, head position, and full-term vaginal delivery receiving epidural labor analgesia. Exclusion Criteria: * have a fever before epidural analgesia, acute infection on admission, incomplete baseline data, fatal fetal malformations or comorbidities, duration from admission to delivery of more than 72 hours or less than 3 hours, or an American Society of Anesthesiologists (ASA) classification of ≥ Ⅲ.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parturients are randomly assigned to either vitamin C(1,2,3) or control. The vitamin C group received 1 g, 2g, and 3g of vitamin C intravenously respectively and the control group received normal saline, administered after the induction of epidural labor anesthesia. There will be 100 cases in each group. The infusion speed will be set at 5ml/min.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

1 product

2 indications

Organization
Kunyue Li
Product
Vitamin C
Indication
Obstetric Labor Complications
Indication
Fever