Recruiting PHASE4 Induction of Labor

New treatment option for Induction of Labor

Official title Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter

ClinicalTrials.gov ID: NCT06803992

What this study is testing

What is Dinoprostone vaginal insert?

Dinoprostone vaginal insert is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for induction of labor.

Also referred to as Propess.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 60, women only

You may be able to join if

  • Pregnant women at term (37 weeks of gestation or more) with singleton
  • pregnancies that are intended for IOL.
  • Initial bishop score \<5
  • No contraindications to receive either treatment.
  • Women who will give informed consent to be included in the study.

You likely can't join if

  • Women with a known hypersensitivity or contraindications to Propess / PGE2.
  • Parity 5 or more
  • Labor contractions more than 4 in 20 min
  • Glaucoma
  • History of previous uterine surgery
  • Hypersensitivity to prostaglandins
See the full eligibility criteria
Who can join
  • Pregnant women at term (37 weeks of gestation or more) with singleton
  • pregnancies that are intended for IOL.
  • Initial bishop score \<5
  • No contraindications to receive either treatment.
  • Women who will give informed consent to be included in the study.
  • Women at or over the age of 18.
What rules you out
  • Women with a known hypersensitivity or contraindications to Propess / PGE2.
  • Parity 5 or more
  • Labor contractions more than 4 in 20 min
  • Glaucoma
  • History of previous uterine surgery
  • Hypersensitivity to prostaglandins
  • Vaginal delivery is contraindicated
  • Active cardiac, renal, pulmonary, or hepatic disease
  • Severe asthma or pulmonary disease

The study team makes the final eligibility decision.

Where it's taking place

  • Afula, Israel

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 years to 60 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Afula, Israel. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.