Not recruiting

Safety Study of Almagate for Pregnant Women with Heartburn and Reflux, Assessing Effects on Mother and Baby

Verified siteRegistered drugNo placebo

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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 safety of a medication called almagate in pregnant women who experience heartburn and reflux. Heartburn is a common condition during pregnancy where a burning sensation is felt in the chest, often after eating. Reflux, also known as acid reflux, occurs when stomach acid flows back into the tube connecting the mouth and stomach, causing discomfort. The medication being tested, almagate, is an oral suspension, which means it is a liquid taken by mouth to help relieve these symptoms.

The purpose of this study is to evaluate how safe almagate is for both the pregnant women and their babies. The study will observe the effects of almagate on the mothers and their babies during pregnancy and after birth. Participants will take almagate for a period of up to 14 days. Throughout the study, doctors will monitor the health of the mothers and their babies, looking at various factors such as the type of delivery, the baby's weight and length at birth, and the overall health of the newborn. The study will also assess the mothers' satisfaction with the use of almagate as an antacid.

Participants will have regular follow-up visits with their healthcare providers to discuss their experiences with almagate and any changes in their symptoms. The study aims to provide valuable information on the safety of using almagate during pregnancy, which can help guide future treatment options for pregnant women experiencing heartburn and reflux.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants are adult pregnant women aged 18-45 years experiencing heartburn or reflux.
Step 2
Initial assessment
An initial assessment is conducted to collect baseline data. This includes checking for conditions like gestational diabetes and hypertensive states of pregnancy.
Step 3
Medication administration
Participants receive almagate in the form of an oral suspension called Almax Forte 1.5 g. The medication is taken orally to manage heartburn and reflux symptoms.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor the safety and effectiveness of almagate. During these visits, the efficacy of the medication is assessed based on the participant's experience and the physician's evaluation.
Patient satisfaction with the treatment is also evaluated using a questionnaire.
Step 5
Delivery visit
At the time of delivery, data is collected on various outcomes such as type of delivery, birth weight, and any complications like abruptio placentae or postpartum hemorrhage.
The newborn's health is assessed through physical examinations and the APGAR score.
Step 6
Post-delivery assessment
A follow-up assessment is conducted to evaluate the long-term effects on the child, including developmental milestones using the ASQ-3™ questionnaire at 24 months of age.

Who can join the trial?

4 criteria

You must be an adult woman who is currently pregnant.
Your age should be between 18 and 45 years old.
You should be experiencing **heartburn**, which is a burning feeling in your chest or throat.
Only women are eligible to participate in this study.

Who cannot join the trial?

5 criteria

Men cannot participate in the study. Only women are eligible.
Individuals who are not pregnant cannot participate. The study is specifically for pregnant women.
Participants must be experiencing **heartburn** or **reflux**. These are conditions where stomach acid causes a burning feeling in the chest or throat.
Participants must be within a certain age range, typically adults, but the exact age range is not specified here.
Individuals who are not considered part of a **vulnerable population** cannot participate. A vulnerable population includes groups like pregnant women who may need special protection in research.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Hospital Universitari General De Catalunya
Verified
Sant Cugat Del Valles, Spain

Trial locations

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Investigated drugs

Almagate is a medication used to relieve symptoms of acidity and heartburn. In this clinical trial, it is being studied to evaluate its safety for pregnant women who experience these symptoms. The trial also aims to understand how the use of almagate might affect the health of the fetus and newborn.

Almagate

What is already known about the treatment

Almagate – Almagate is administered orally, typically in the form of chewable tablets or liquid suspension. It is currently being studied in a Phase IV clinical trial to evaluate its safety in pregnant women experiencing heartburn and reflux, as well as its effects on perinatal outcomes. The main therapeutic indication for almagate is the relief of symptoms associated with heartburn and acid reflux. At the molecular level, almagate works by neutralizing stomach acid, thereby reducing acidity and alleviating discomfort. It is classified pharmacologically as an antacid.

Investigated diseases

Heartburn and Gastroesophageal Reflux Disease (GERD) – Heartburn is a burning sensation in the chest, often after eating, which might worsen when lying down or bending over. It is a symptom of gastroesophageal reflux disease (GERD), where stomach acid frequently flows back into the tube connecting your mouth and stomach. This backwash can irritate the lining of your esophagus. Over time, GERD can lead to more serious health problems if not managed. Symptoms may include a sour taste in the mouth, difficulty swallowing, and chest pain. Lifestyle changes and medications can help manage the symptoms.