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Dietary Supplement

Prospective Treatment Group for Pregnancy

Phase 1

Waitlist Available

Led By Marie Forgie, DO

Research Sponsored by Aurora Health Care

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the intervention (measured from time of induction to delivery)

Awards & highlights

Study Summary

This trial aims to study if giving calcium carbonate to women in labor can make the labor process faster and safer. Researchers believe that calcium carbonate can reduce the need for certain medications during labor, lower the chances

Who is the study for?

This trial is for pregnant individuals who are about to undergo labor induction. The specific details on eligibility criteria were not provided, so it's important to consult with the study organizers for more information.Check my eligibility

What is being tested?

The trial is testing if calcium carbonate can help during labor induction by reducing the time and dosage of oxytocin needed, lowering the chances of difficult labor (dystocia), and cutting down cesarean deliveries without harming mother or baby.See study design

What are the potential side effects?

While detailed side effects are not listed, calcium carbonate is generally considered low-risk. Possible side effects may include digestive discomfort like gas or constipation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the intervention (time on calcium carbonate to delivery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the intervention (time on calcium carbonate to delivery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the intervention (time on calcium carbonate to delivery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of induction time

Rate of labor dystocia

Secondary outcome measures

Blood loss

Gastrointestinal side effects

Neonatal composite adverse outcomes

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospective Treatment GroupExperimental Treatment1 Intervention

Patients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction

Group II: Retrospective Historical Control GroupActive Control1 Intervention

Patients who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone for labor induction and were not treated with calcium carbonate

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Calcium Carbonate

2011

Completed Phase 4

~7280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aurora Health CareLead Sponsor

43 Previous Clinical Trials

15,995 Total Patients Enrolled

Marie Forgie, DOPrincipal InvestigatorAurora Health Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks associated with the Prospective Treatment Group for individuals undergoing treatment?

"Given that this is a Phase 1 trial, the safety of the Prospective Treatment Group has been rated as 1 on our scale. This indicates that there is minimal data available to support both its safety and efficacy at this stage."

Answered by AI

What is the primary objective of conducting this medical study?

"The primary goal of this research is to evaluate the incidence of labor dystocia throughout the intervention period (commencing from induction with oxytocin until delivery). Secondary assessments include measuring postpartum hemorrhage rates (equal to or exceeding 500mL), where it is anticipated that individuals in the treatment arm will encounter lower occurrences compared to those under historical controls. Additionally, blood loss and gastrointestinal adverse reactions will be monitored; participants receiving treatment are expected to have reduced blood loss and report fewer gastrointestinal side effects than their counterparts in the retrospective control group."

Answered by AI

Are they currently enrolling participants for this investigation?

"The ongoing clinical trial, as detailed on clinicaltrials.gov, is presently not open for participant recruitment. This particular study was first listed on the platform on April 1st, 2024 and underwent its latest revision also in this date. Despite this specific trial being closed to new participants, there are currently a total of 87 other active clinical trials enrolling eligible candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Calcium Carbonate on Labor Induction

Marie Forgie 2024. "Calcium Carbonate on Labor Induction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06352775.