CompletedNot Applicable

Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.

Tanzania550 participantsStarted 2016-10-01

Plain-language summary

This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the intermittent auscultation protocols at KCMC, and to validate whether or not a handheld Doppler device can perform the fetal scalp stimulation test accurately.

Who can participate

Age range

15 Years – 50 Years

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: * Gestational Age ≥ 37 weeks * Singleton gestation * Cephalic presentation * First stage of labor * Fetal distress diagnosed in the labor ward by either FHR \>160 or \<110, and/or grade 2-3 meconium-stained liquor Exclusion Criteria: * Chorioamnionitis * Known fetal anomaly * Antepartum hemorrhage * Eclampsia * Other maternal/fetal factors precluding vaginal delivery

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

Feasibility as measured by completion of all 3 study objectives

Timeframe: Day 1

Predicted fetal acidosis from cord blood pH (at thresholds of cord blood pH<7.0, 7.1, and 7.2)

Timeframe: Day 1

Trial details

NCT IDNCT02862925

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-30

View on ClinicalTrials.gov More Fetal Distress trials