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Study on the Effectiveness of Oral Sodium Bicarbonate and Intravenous Hyoscine Butylbromide for Facilitating Natural Childbirth in Pregnant Women Induced for Labor

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the process of childbirth, specifically looking at ways to help pregnant women deliver their babies without the need for surgery. The study will test two treatments: oral sodium bicarbonate capsules and intravenous butylscopolamine bromide injections. Sodium bicarbonate is commonly known as baking soda and is used in medicine to neutralize stomach acid. Butylscopolamine bromide, also known as Buscopan, is used to relieve muscle spasms in the stomach and intestines.

The purpose of the study is to see if these treatments can help women who are being induced to go into labor deliver their babies naturally, without needing a cesarean section or other surgical methods. The study will have four groups, with some participants receiving the actual treatments and others receiving a placebo, which looks like the treatment but has no active ingredients. This helps researchers understand the true effects of the treatments.

Participants in the study will be monitored throughout their labor to see if the treatments help in achieving a natural delivery. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results. The trial is expected to continue until early 2025, with the aim of providing valuable insights into improving childbirth outcomes for women undergoing labor induction.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, participants are randomly assigned to one of four groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

  2. Step 2

    Receiving medications

    Participants may receive one of the following treatments: oral bicarbonate, intravenous butylscopolamine bromide, or a placebo. The placebo is a tablet that looks the same as the bicarbonate tablet but does not contain the active substance.

    The oral bicarbonate is given in the form of 500 mg capsules. The dosage and frequency of administration will be determined by the study protocol.

    The intravenous butylscopolamine bromide is administered as a 20 mg/ml solution for injection. The dosage and frequency will also be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, participants will undergo regular monitoring and assessments to evaluate the progress of labor and the effectiveness of the treatment.

    These assessments may include physical examinations and other tests as required by the study protocol.

  4. Step 4

    Completion of the trial

    The trial aims to facilitate spontaneous delivery and reduce the need for operative delivery, such as cesarean section, vacuum, or forceps.

    Upon completion of the trial, participants will have a final assessment to determine the outcome of the delivery and any effects of the treatment.

Who can join the trial?

6 criteria

  • Participants must be first-time mothers (women who have not given birth before).
  • Participants must be undergoing induction of labor (a medical process to start labor).
  • Participants must be carrying a single baby (not twins or more).
  • The baby must be in a head-down position (cephalic presentation) ready for birth.
  • Participants must be at full term (close to their due date).
  • Participants must be female.

Who cannot join the trial?

6 criteria

  • Participants who are not currently pregnant cannot join the study.
  • Only females are eligible; males cannot participate.
  • Participants must be within the age range specified by the study.
  • Participants who have any medical condition that might interfere with the study cannot join.
  • Participants who are unable to give informed consent cannot participate.
  • Participants who are part of a vulnerable population, such as those who cannot make decisions for themselves, may not be eligible.
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Investigated drugs

  • Oral Bicarbonate

    is a medication that is taken by mouth. In this trial, it is being used to help pregnant women who are being induced for labor. The goal is to see if it can make it easier for them to have a natural birth without needing surgery. Oral bicarbonate works by balancing the acid levels in the body, which might help the muscles in the uterus work better during labor.

  • Intravenous Butylscopolamine Bromide

    is a medication given through a vein, directly into the bloodstream. It is used in this trial to help pregnant women who are being induced for labor. The purpose is to see if it can help them have a natural birth without surgery. This medication works by relaxing the muscles in the body, including those in the uterus, which might make it easier for the baby to be born naturally.

What is already known about the treatment

  • Bicarbonate

    Bicarbonate is administered orally and is currently being studied in clinical trials to help facilitate natural childbirth in women undergoing labor induction. It is not yet widely recognized in medical literature for this specific use. The main therapeutic indication is to aid in spontaneous delivery. At the molecular level, bicarbonate works by neutralizing acids in the body, which may help improve muscle function during labor. It is classified pharmacologically as an antacid.

  • Butylscopolamine bromide

    Butylscopolamine bromide is given intravenously and is being investigated in clinical trials to assist in natural childbirth for women with induced labor. It is not yet a standard treatment in medical literature for this purpose. The primary therapeutic indication is to facilitate spontaneous delivery. On a molecular level, it works by relaxing smooth muscles, which can help ease contractions during labor. It is classified as an antispasmodic medication.

Investigated diseases

Childbirth – Childbirth, also known as labor and delivery, is the process by which a baby is born. It typically begins with the onset of regular uterine contractions, which help to dilate the cervix and allow the baby to pass through the birth canal. Labor is divided into three stages: the first stage involves the dilation of the cervix, the second stage is the delivery of the baby, and the third stage is the delivery of the placenta. The progression of labor can vary greatly among individuals, with some experiencing a rapid process and others having a prolonged labor. Factors such as the position of the baby, the strength of contractions, and the mother's pelvic structure can influence the course of childbirth. In some cases, medical interventions may be necessary to assist with delivery.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511848-55-00Estimated enrolment3 000 patientsSponsorOslo University Hospital HF

sourced from the EU Clinical Trials Register and site verification

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