The Stimulation To Induce Mothers Study

Официальное название

The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial

Обзор

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. The central hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery, improves patient-centered outcomes such as childbirth satisfaction, labor agentry, and pain scores, and reduces adverse neonatal and maternal outcomes in nulliparous women. The investigators will pursue the following specific aims: 1) Assess the effectiveness of intrapartum nipple stimulation on the rate of spontaneous vaginal delivery in nulliparous women, 2) Breastfeeding as the sole source of nutrition at time of maternal hospital discharge (Primary Aims); 3) Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life, 4) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes, 5) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes and 6) In a sub-cohort of women who are enrolled in the trial, investigators will measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern.

Подробное описание

Primary Objectives

1. 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. Determine if women who perform intrapartum nipple stimulation report differences in pain scores during labor, labor agentry and satisfaction scores, postpartum depression scores, and breastfeeding success compared to women who receive only intrapartum exogenous oxytocin infusion. 4. Determine if women who perform intrapartum nipple stimulation to induce labor have similar fetal and neonatal outcomes compared to women who receive only intrapartum exogenous oxytocin infusion. 5. Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life 6. At Yale, to measure the change in oxytocin concentration from baseline over the course of labor induction in patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion. 7. At Yale, to measure circulating plasma and urine concentrations of proteins, microRNA, and small molecules using unbiased "omics" approaches, comparing patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion, un-ripened/unlabored control patients, and patients in spontaneous labor.

Вмешательства

• Устройство Electric breast pump
  Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor for at least 2 hours
• Препарат Exogenous oxytocin intravenous infusion without nipple stimulation.
  Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care

Первичные конечные точки

• Spontaneous vaginal delivery [Срок оценки: At delivery]
• Breastfeeding as the sole source of nutrition (BSSN) [Срок оценки: up to 72 hours following delivery]

Вторичные конечные точки (12)

• Operative vaginal delivery [Срок оценки: At delivery]
• Cesarean delivery [Срок оценки: At delivery]
• Labor induction duration [Срок оценки: At delivery]
• Number of Participants with Postpartum hemorrhage [Срок оценки: From delivery to 24 hours postpartum]
• Number of Participants with Severe Postpartum hemorrhage [Срок оценки: From delivery to 24 hours postpartum]
• Number of participants with suspected infection [Срок оценки: 3-7 days postpartum]
• Lactational mastitis [Срок оценки: After delivery to 12 weeks postpartum]
• Number of maternal deaths [Срок оценки: immediately prior to up to immediately post delivery]
• Maternal Intensive Care Unit admission [Срок оценки: 3-7 days postpartum]
• Neonatal Intensive Care Unit admission [Срок оценки: up to 28 days following birth]
• Neonatal Apgar score ≤3 at 5 minutes of life [Срок оценки: At 5 minutes after birth]
• Umbilical acidemia [Срок оценки: At delivery]

Критерии участия

Критерии включения

• Nulliparous
• Gestational age 36 0/7 weeks and greater at enrollment
• Singleton gestation
• 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

Критерии исключения

• Unable to understand English or Spanish
• Prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy
• 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 time of 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 (e.g., twins, triplets, and higher-order multiples)
• Intrauterine fetal death
• 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)
• HIV infection (nipple stimulation is not encouraged given the recommendation for these mothers not to breastfeed)
• Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
• History of mastectomy or other contraindication to use of electronic breast pump
• Known allergic reactions to components of the electronic breast pump or to synthetic oxytocin intravenous solution
• Significantly impaired consciousness or executive function (e.g., intubated or sedated)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 3 центра

• Yale New Haven Hospital — New Haven
• Northwestern Memorial Hospital — Chicago
• Weill Cornell Medicine — New York

Публикации

• Tortal D, Shabanova V, Taylor S, Xu X, McAdow M, Stetson B, McCollum S, Sanchez E, Adjakple A, Leventhal J, Son M. Stimulation Therapy to Induce Mothers: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 29;13:e63463. doi: 10.2196/63463. PMID 39207839

Идентификаторы

NCT: NCT05079841 · 2000031338 · 1R01HD111633-01 · 231888-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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