Intravaginal Magnesium Sulfate vs Intravenous Dexamethasone for Labor Acceleration: A Bayesian Adaptive Randomized Controlled Trial

Abstract

Background Labor progression and pain management are critical challenges in obstetric care. While intravenous dexamethasone has shown efficacy in accelerating labor, its systemic risks limit its use. Intravaginal magnesium sulfate offers a potential alternative, but comparative studies are lacking. This study aimed to compare the efficacy and safety of these interventions for labor acceleration.

Methods A Bayesian adaptive randomized controlled trial was conducted with 150 primiparous women in the latent phase of labor, allocated to three groups: intravaginal magnesium sulfate (50%, 10cc), intravenous dexamethasone (8mg), and routine care. Primary outcomes included labor duration and Bishop score changes, while secondary outcomes assessed neonatal Apgar scores and maternal adverse effects. Bayesian and frequentist analyses were employed, with adjustments for baseline imbalances.

Results Magnesium sulfate significantly reduced latent phase duration by 3.0 hours (95% CrI: 2.2 to 3.9) and active phase duration by 1.99 hours (1.03 to 2.99), outperforming dexamethasone (1.8 and 1.09 hours, respectively). Both interventions achieved comparable peak Bishop score improvements at 6 hours (+3.06 vs. +3.05 points). Magnesium sulfate demonstrated superior safety, avoiding systemic risks associated with dexamethasone.

Conclusions This study suggests intravaginal magnesium sulfate may be preferable to dexamethasone for labor acceleration, offering comparable efficacy with potentially fewer systemic risks. While both treatments are effective, magnesium sulfate could be considered as a first-line option, with dexamethasone reserved for specific cases.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

IRCT74207

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Ethics Committee/IRB of Alborz University of Medical Sciences (ABZUMS), Kamali Hospital, Karaj, Iran, gave ethical approval for this work (approval code: IR.ABZUMS.REC.1403.076). Written informed consent was obtained from all participants.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The full study protocol and statistical analysis plan are available upon request from the corresponding author.

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