BridgeMD
New treatment option for Labor Dystocia
Official title Calcium Carbonate to Augment Labor Contractions
ClinicalTrials.gov ID: NCT06580782
What this study is testing
What is Calcium Carbonate 500 MG?
Calcium Carbonate 500 MG is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for labor dystocia.
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
- The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 18 years or older
- Nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation)
- Gestational age above 36 weeks, at enrollment
- Present for induction or augmentation of labor inclusive of medical indication, elective induction at greater than 39 weeks' gestation, trial of...
- Singleton gestation (a multiple gestation reduced to a singleton, either spontaneously or therapeutically, before 14 0/7 weeks of gestation is...
You likely can't join if
- Unable to understand or read English
- Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal...
- Non-vertex presenting fetus at enrollment
- Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes...
- Multi-fetal gestation (twins, triplets, and higher order multiples)
- Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate...
See the full eligibility criteria
- 18 years or older
- Nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation)
- Gestational age above 36 weeks, at enrollment
- Present for induction or augmentation of labor inclusive of medical indication, elective induction at greater than 39 weeks' gestation, trial of labor after cesarean
- Singleton gestation (a multiple gestation reduced to a singleton, either spontaneously or therapeutically, before 14 0/7 weeks of gestation is acceptable)
- Ability to give informed consent
- Planned to undergo initiation of oxytocin infusion by their maternity care provider
- Unable to understand or read English
- Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment
- Non-vertex presenting fetus at enrollment
- Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)
- Multi-fetal gestation (twins, triplets, and higher order multiples)
- Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity.
- Deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature \< 36 weeks of gestation.
- Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
- Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission)
- Known severe fetal growth restriction (estimated fetal weight \<3rd percentile) or abnormal umbilical artery Doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission)
- Participation in another treatment study that influences management of labor and delivery or perinatal morbidity or mortality
- Known allergic reactions to synthetic oxytocin intravenous solution or to Calcium Carbonate
- Significantly impaired consciousness or executive function (e.g., intubated or sedated)
- Patients treated with calcium channel blockers such as nifedipine or magnesium.
- Chronic renal failure and hyperphosphatemia.
- Inability to tolerate oral intake (i.e., nausea/vomiting)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. 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.