CompletedPhase 4

Medical Management of Late Intrauterine Death.

60 participantsStarted 2008-05

Plain-language summary

The purpose of this study is to assess the therapeutic efficacy and safety of isosorbide dinitrate-oxytocin in combination in the management of late intrauterine foetal death.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Closed cervix without evidence of cervical dilation or baseline uterine activity. * A Bishop score of \<5, having intact membranes. * Gestation greater than or equal to 20 weeks established by the date of menstruation or by fetometry and ultrasound-confirmed late IUFD. Exclusion Criteria: * Multiple pregnancies. * IUFD after late foeticide or the management of specific medical conditions associated with an increase in the risk of IUFD. * Patients with a history of hypertension. * Women with a history of unexplained antepartum haemorrhage, pelvic dystocia or any another counter-indications where medications were used.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rates of uterine expulsion in the women who received the isosorbide dinitrate-oxytocin regimen

Timeframe: within 15 hours of administration

Trial details

NCT IDNCT02488642

SponsorNational Institute of Perinatology

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Cervical Pregnancy trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.