Efficacy of Oral Sodium Hydrogen Carbonate and Intravenous Hyoscine Butylbromide in Facilitating Spontaneous Delivery in Labor Induction: A Randomized Controlled Trial

The primary objective of this study is to evaluate the **efficacy** of oral bicarbonate and intravenous butylscopolamine bromide in facilitating spontaneous (non-operative) delivery in pregnant female participants undergoing induction of labor. This is clinically relevant as it aims to enhance the natural childbirth process, potentially reducing the need for operative interventions, which can carry additional risks and recovery time for both the mother and the newborn.

The clinical trial focuses on assessing the efficacy of oral bicarbonate and intravenous butylscopolamine bromide to facilitate spontaneous delivery in pregnant female participants undergoing **induction of labor**. The study population comprises nulliparous women with a singleton fetus in cephalic presentation at term. Participants are exclusively female, with an age range corresponding to adults of childbearing age. The trial does not include male subjects, and the population is considered vulnerable due to the nature of pregnancy. The sponsor has not provided information regarding the total number of participants. Selection criteria emphasize the inclusion of women experiencing their first childbirth, with no mention of specific lifestyle considerations such as diet or physical activity. The trial's design inherently excludes multiparous women and those with multiple gestations or non-cephalic presentations.

The clinical trial is designed as a **randomized**, **double-blind**, placebo-controlled, four-arm study to evaluate the efficacy of oral bicarbonate and intravenous butylscopolamine bromide in facilitating spontaneous (non-operative) delivery in pregnant female participants undergoing induction of labor. The trial will span from January 1, 2023, to February 1, 2025, with the primary objective of comparing spontaneous versus operative delivery, where operative delivery is defined as cesarean delivery, vacuum, or forceps. Participants will be nulliparous women with a singleton fetus in cephalic presentation at term.

The study will involve several key visits, beginning with an inclusion (screening) visit to assess eligibility based on the inclusion criteria. Following successful screening, participants will be randomized into one of four arms: oral bicarbonate, intravenous butylscopolamine bromide, placebo tablets, or placebo solution. The trial will include follow-up visits to monitor the progress of labor and the administration of the investigational products. The end-of-study visit will occur after delivery to assess the primary endpoint and gather any additional data required for the study's completion.

Participant involvement is expected to last for the duration of labor induction and delivery, with the maximum treatment period being one day. Conditions that may lead to early termination from the study include withdrawal of consent, adverse events, or any medical condition that contraindicates continued participation. The trial is conducted under strict adherence to ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the administration of **Sodium Bicarbonate** 500 mg capsules, which are formulated as hard capsules. The active substance, **sodium hydrogen carbonate**, is administered orally. The maximum daily dose is 12 grams, with a total treatment period of one day. This experimental medication is intended to facilitate spontaneous delivery in pregnant participants undergoing induction of labor.

**Buscopan Ampoules** 20 mg/ml solution for injection is another experimental treatment used in this trial. The active substance is **hyoscine butylbromide**, and the pharmaceutical form is a solution for injection. The medication is administered via intravenous injection, with a maximum daily dose of 60 mg over a one-day treatment period. This treatment aims to assist in the facilitation of spontaneous delivery.

The trial also includes the use of **Sodium Chloride Fresenius Kabi Italia 0.9% Solution for infusion** as a non-experimental treatment. The active substance is **sodium chloride**, and it is provided in a solution for infusion form. The administration route is through intravenous bolus injection or IV infusion, with a maximum daily dose of 3 ml over a one-day treatment period. This solution serves as a standard-of-care therapy in the trial.

A **placebo** is utilized in the study, designed to match the size and appearance of the bicarbonate tablets. The contents of the placebo tablets are detailed in the Summary of Product Characteristics (SmPC). The placebo serves as a comparator treatment to evaluate the efficacy of the experimental medications.

The efficacy of the clinical trial will be assessed by evaluating the primary endpoint, which is the rate of **spontaneous** versus operative delivery. Operative delivery is defined as cesarean delivery, vacuum, or forceps. The trial is designed as a double-blind, randomized, placebo-controlled, four-arm study to determine the effectiveness of oral bicarbonate and intravenous butylscopolamine bromide in facilitating spontaneous (non-operative) delivery in pregnant female participants undergoing induction of labor.