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Study on Progesterone to Prevent Preterm Birth in Pregnant Women with Placenta Previa

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 condition known as placenta previa, which can lead to preterm birth. Placenta previa occurs when the placenta covers the cervix, which can cause complications during pregnancy. The study will explore the use of a treatment involving the hormone progesterone. Progesterone is a naturally occurring hormone that plays a crucial role in maintaining pregnancy. In this trial, progesterone will be administered to pregnant women diagnosed with placenta previa between 18 and 24 weeks of pregnancy.

The purpose of the study is to determine if progesterone can help prevent preterm births in women with placenta previa. Participants in the study will receive progesterone treatment, while others will not receive any treatment, allowing researchers to compare the outcomes. The study will monitor various factors, including the rate of preterm births before 37 weeks of pregnancy, the duration of pregnancy, and any side effects experienced by the mothers. The study will also look at the health of the newborns, including their birth weight and any need for special care after birth.

Throughout the study, participants will be closely monitored to ensure their safety and the health of their babies. The trial aims to provide valuable insights into whether progesterone can be an effective treatment for preventing preterm births in women with placenta previa, potentially improving outcomes for both mothers and their babies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the criteria: being pregnant with one baby, diagnosed with placenta previa between 18 and 24 weeks of pregnancy, and having no other high-risk factors for early birth.

  2. Step 2

    Treatment initiation

    The treatment involves the use of progesterone, administered through the vagina. This treatment starts between 18 and 24 weeks of pregnancy.

  3. Step 3

    Treatment duration

    The treatment continues until the end of the pregnancy or until the occurrence of early birth before 37 weeks of pregnancy.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment in preventing early birth. This includes checking the duration of the pregnancy, the health of the newborn, and any side effects experienced by the mother.

  5. Step 5

    Completion of the study

    The study concludes with the birth of the baby. The primary focus is on the number of births occurring before 37 weeks of pregnancy.

Who can join the trial?

4 criteria

  • Must be a woman who is pregnant.
  • Pregnancy must involve only one baby, not twins or more.
  • Must have been diagnosed with **placenta previa** between 18 and 24 weeks of pregnancy. Placenta previa is a condition where the placenta is located low in the uterus and covers part or all of the cervix.
  • Should not have any other high-risk factors for giving birth early, known as **preterm birth**. Preterm birth is when a baby is born before 37 weeks of pregnancy.

Who cannot join the trial?

4 criteria

  • Women who do not have a condition called placenta previa. This is when the placenta, which provides nutrients to the baby, is located too low in the uterus and covers the cervix.
  • Women who are not at risk of preterm birth. This means giving birth before 37 weeks of pregnancy.
  • Men cannot participate in this study.
  • Individuals who are not considered part of a vulnerable population. This term refers to groups who may need special protection or care, such as pregnant women.
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Investigated drugs

Progesterone is a hormone used in this trial to help prevent preterm births in women who have a condition called placenta previa. The treatment starts between the 18th and 24th week of pregnancy. The goal is to see if using progesterone can reduce the chances of giving birth too early, which is before 37 weeks of pregnancy. The study will look at how well progesterone works in lowering the rates of early births and will also check for any side effects in the mothers.

What is already known about the treatment

Progesterone – Progesterone is administered as an injection or vaginal gel, depending on the specific treatment protocol. It is currently being studied in clinical trials for its effectiveness in preventing preterm birth in women with placenta previa. The main therapeutic indication is to reduce the risk of preterm birth, which can lead to complications for both the mother and baby. At the molecular level, progesterone works by maintaining the uterine lining and reducing uterine contractions, which helps prolong pregnancy. It is classified as a progestin, a type of hormone that plays a crucial role in the menstrual cycle and pregnancy.

Investigated diseases

  • Placenta Previa

    This condition occurs when the placenta covers the cervix, either partially or completely, during pregnancy. It can lead to bleeding, especially in the later stages of pregnancy. As the pregnancy progresses, the placenta may move away from the cervix, resolving the issue. However, if it remains in place, it can cause complications during delivery. The condition is usually identified through routine ultrasound examinations. It requires careful monitoring to manage any potential risks to the mother and baby.

  • Preterm Birth

    This refers to a birth that occurs before 37 weeks of gestation. It can happen spontaneously or be medically induced due to health concerns for the mother or baby. Preterm birth can lead to various health challenges for the newborn, as they may not be fully developed. The earlier the birth, the higher the risk of complications. Factors contributing to preterm birth include multiple pregnancies, infections, and chronic conditions. Monitoring and preventive measures are essential to manage the risk of preterm birth.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507763-18-01Estimated enrolment142 patientsSponsorAmsterdam UMC Stichting

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