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A Phase IV, Multicenter, Open-label, Single-arm Study to Evaluate the Safety of Almagate in Pregnant Women With Heartburn and Reflux, and Perinatal Outcomes in the Foetus and Newborn.
EU CTIS ID: 2024-515381-14-00
What this study is testing
The primary objective of this study is to assess the safety of almagate in pregnant women with heartburn and reflux and the perinatal outcomes in the foetus and newborn.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult pregnant women (age 18-45 years) with heartburn.
You likely can't join if
- Risk pregnancy. A high-risk pregnancy is defined as one that meets any of the following criteria: - Morbid obesity (BMI ≥ 40) - History of miscarriage (two or more previous miscarriages not performed voluntarily) - History of cervical insufficiency (history of the cervix's inability to carry a pregnancy to term) - Previous chromosomal abnormality (inherited fetal abnormalities) - Previous ectopic pregnancy - Previous gestational trophoblastic disease - Previous premature birth - Endocrinopathies (disorders of the endocrine gland, for example, hyper/hypothyroidism, prolactinoma, adrenal gland disorders) - Cardiovascular risk (WHO class III) - Twin pregnancy - Maternal infection diagnosed during pregnancy - Rh (D) isoimmunization and others - Current severe mental illness (psychotic disorders that occur continuously or episodically during pregnancy) two years or older). - Severe anemia (hemoglobin levels below 9 g/dL or hematocrit below 25%) - Suspected fetal malformation and/or fetal genetic/chromosomal abnormality.- - History of perinatal death. - Alcohol or other drug dependence. - Multiple gestations with three or more fetuses. - Threatened preterm labor. - Premature rupture of membranes.
- Patients with diagnosed pre-gestational hypertension (HTN>140/90).
- Patients with eclampsia and preeclampsia
- Patients with pregestational diabetes mellitus or poorly controlled or corrected gestational diabetes with diet and insulin
- Lack of informed consent.
- criteria for discontinuation and premature withdrawal
See the full eligibility criteria
Who can join
- Adult pregnant women (age 18-45 years) with heartburn.
What rules you out
- Risk pregnancy. A high-risk pregnancy is defined as one that meets any of the following criteria: - Morbid obesity (BMI ≥ 40) - History of miscarriage (two or more previous miscarriages not performed voluntarily) - History of cervical insufficiency (history of the cervix's inability to carry a pregnancy to term) - Previous chromosomal abnormality (inherited fetal abnormalities) - Previous ectopic pregnancy - Previous gestational trophoblastic disease - Previous premature birth - Endocrinopathies (disorders of the endocrine gland, for example, hyper/hypothyroidism, prolactinoma, adrenal gland disorders) - Cardiovascular risk (WHO class III) - Twin pregnancy - Maternal infection diagnosed during pregnancy - Rh (D) isoimmunization and others - Current severe mental illness (psychotic disorders that occur continuously or episodically during pregnancy) two years or older). - Severe anemia (hemoglobin levels below 9 g/dL or hematocrit below 25%) - Suspected fetal malformation and/or fetal genetic/chromosomal abnormality.- - History of perinatal death. - Alcohol or other drug dependence. - Multiple gestations with three or more fetuses. - Threatened preterm labor. - Premature rupture of membranes.
- Patients with diagnosed pre-gestational hypertension (HTN>140/90).
- Patients with eclampsia and preeclampsia
- Patients with pregestational diabetes mellitus or poorly controlled or corrected gestational diabetes with diet and insulin
- Lack of informed consent.
- criteria for discontinuation and premature withdrawal
- Presence of undiagnosed gastrointestinal or rectal bleeding, severe hemorrhoidal syndrome*, or chronic digestive diseases accompanied by persistent pre-gestational diarrhea. *Severe hemorrhoidal syndrome is defined as: characterized by the presence of hemorrhoids in an advanced stage with intense symptoms and associated complications: - Intense and persistent pain, especially if there is hemorrhoidal thrombosis. - Heavy, intermittent, or constant bleeding, which can lead to anemia. - Irreducible hemorrhoidal prolapse, that is, when the hemorrhoids remain permanently outside the anus and cannot be manually reduced. - Thrombosis or ulceration, which can lead to increased inflammation, infection, and necrosis in severe cases. - Significant impact on quality of life, with difficulty sitting, defecating, or performing daily activities. - In these cases, medical treatment is usually insufficient, and surgery is considered the main option, such as hemorrhoidectomy or less invasive techniques such as rubber band ligation or transanal hemorrhoidal dearterialization (THD).
- Other circumstances or difficulties that, in the researcher's judgment, may increase the risk to the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study.
- Patient unable to give consent, or patient of consenting age but under guardianship, or vulnerable patients.
- Patients must be in the first trimester of pregnancy; those eligible cannot be included until week 13+0 of pregnancy (all pregnancies before or at 13.0 weeks of gestation are excluded). Pregnancy is dated by measuring the CRL distance in the first trimester or, failing that, by the date of the last menstrual period.
- Being participating or having participated in another clinical trial in the 6 months prior to the inclusion in this study.
- Prior treatment with medications: antacids (except Almax), proton pump inhibitors (PPIs) or anti-histamine 2 blockers (anti-H2) during this pregnancy.
- Hypersensitivity to almagate or any of its excipients
- Patients with Alzheimer's disease.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.