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

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What is this study about?

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.

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 treatment initiation

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

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Tergooiziekenhuizen	Hilversum	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Flevoziekenhuis Stichting	Almere	The Netherlands
Rode Kruis Ziekenhuis B.V.	Beverwijk	The Netherlands
Zaans Medisch Centrum Stichting	Zaandam	The Netherlands
Dijklander Ziekenhuis	Hoorn	The Netherlands
Ajnmhjqcl Uvl	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.01.2024

Trial locations

Investigated drugs:

Progesterone

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.

Investigated diseases:

Placenta praevia

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 ID:

2023-507763-18-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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