The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial
概览
- 阶段
- 4 期
- 干预措施
- Electric breast pump
- 疾病 / 适应症
- Oxytocin
- 发起方
- Yale University
- 入组人数
- 988
- 试验地点
- 3
- 主要终点
- Spontaneous vaginal delivery
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Intrapartum nipple stimulation
Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.
干预措施: Electric breast pump
Exogenous oxytocin intravenous infusion
Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.
干预措施: Exogenous oxytocin intravenous infusion without nipple stimulation.
结局指标
主要结局
Spontaneous vaginal delivery
时间窗: At delivery
Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean
Breastfeeding as the sole source of nutrition (BSSN)
时间窗: up to 72 hours following delivery
Number of participants using breastfeeding as the sole source of nutrition (BSSN) at time of maternal discharge or 72 hours of life (whichever is sooner)
次要结局
- Labor induction duration(At delivery)
- Number of Participants with Severe Postpartum hemorrhage(From delivery to 24 hours postpartum)
- Neonatal Apgar score ≤3 at 5 minutes of life(At 5 minutes after birth)
- Number of maternal deaths(immediately prior to up to immediately post delivery)
- Neonatal Intensive Care Unit admission(up to 28 days following birth)
- Composite neonatal severe morbidity measure(up to 28 days following delivery)
- Cesarean delivery(At delivery)
- Operative vaginal delivery(At delivery)
- Number of Participants with Postpartum hemorrhage(From delivery to 24 hours postpartum)
- Number of participants with suspected infection(3-7 days postpartum)
- Lactational mastitis(After delivery to 12 weeks postpartum)
- Maternal Intensive Care Unit admission(3-7 days postpartum)
- Umbilical acidemia(At delivery)
- Percent newborn weight loss(At 72 hours of life or birth hospitalization discharge, whichever is earlier)