The Stimulation To Induce Mothers Study

What Was Tested

The trial (phase 4) is built around Oxytocin.

The investigators propose a parallel group randomized clinical trial of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term.

It had two arms (groups): Intrapartum nipple stimulation (experimental) and Exogenous oxytocin intravenous infusion (active comparator).

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.

The registry classes the interventions as device and drug.

More on the Plan

To determine whether intrapartum nipple stimulation therapy with or without synthetic oxytocin changes the likelihood of achieving a spontaneous vaginal delivery compared to receipt of synthetic oxytocin infusion without nipple stimulation to induce labor. 2.

Breastfeeding as the sole source of nutrition at time of maternal hospital discharge Secondary Objectives (if applicable) The secondary objectives are as follows: 1.

Determine whether intrapartum nipple stimulation therapy with or without synthetic oxytocin changes the likelihood of achieving a spontaneous vaginal delivery compared to receipt of synthetic oxytocin infusion without nipple stimulation to induce labor. 2.

Determine if women who perform intrapartum nipple stimulation to induce labor have differences in other obstetric and maternal outcomes 3.

Who Took Part

Enrollment: 933 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Gestational age 36 0/7 weeks and greater at enrollment. Planned to undergo initiation of exogenous oxytocin infusion by their maternity care provider. Spontaneous rupture of membranes or if membranes intact, modified Bishop score ≥5 and cervix dilated \<6 cm within one hour of enrollment. Ability to give informed consent.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: unable to understand english or spanish; prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy; non-vertex presenting fetus at time of enrollment.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-11-15 with completion listed for 2028-11.

It ran at 3 sites in United States (3).

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Spontaneous vaginal delivery (time frame: At delivery). Breastfeeding as the sole source of nutrition (BSSN) (time frame: up to 72 hours following delivery).

It also tracked 14 secondary outcomes, for example Operative vaginal delivery, Cesarean delivery, Labor induction duration, Number of Participants with Postpartum hemorrhage, Number of Participants with Severe Postpartum hemorrhage and Number of participants with suspected infection.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 933 people.

With 933 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.