The LINO Study - Labor Induction Inpatient and Outpatent: A Pilot- and Feasibility Study of Low-risk Nulliparious Women Using 25 mcg Oral Misoprostol for Labor Induction in an Inpatient and Outpatent Setting in Norway.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Deliveries outside the hospital
研究概览
简要总结
The rate of labor induction has been steadily increasing over the last years, both worldwide and in Norway. Norwegian women are hospitalized when prostaglandins are used to induce labor. In Denmark, a neighboring country to Norway, women have been offered outpatient induction of labor using oral misoprostol for several years.
The overall aim of this study is to investigate if outpatient induction of labor is beneficial in a Norwegian setting. This includes:
- To investigate the clinical outcomes and feasibility of inducing in an outpatient setting compared to an inpatient setting in Norway
- To explore low-risk nulliparous women's experiences of labor induction in inpatient and outpatient settings.
This is a non-randomized prospective pilot- and feasibility study, collecting data from electronical records. In addition, the study participants are invited to write a diary during the labor induction process and a questionnaire six weeks postpartum. Eligible patients include low-risk nulliparous women induced with low-dose oral misoprostol.
详细描述
The labor induction rate in Norway has increased from 10,5 % in 2000 to 26,1 % in 2019. This represents an important shift in the obstetric care, making labor induction one of the most common obstetrical interventions. The increase alters the population being induced, as it now includes more low-risk births compared to 20 years ago. The low risk labor inductions might not require the same repeated cardiotocography and inpatient care before onset of active labor as complicated pregnancies.
In 2017, a 25 μg misoprostol tablet for oral administration was approved for labor induction in the Nordic countries. Oral administration is user friendly, and low-dose orally administrated misoprostol is considered to have a favorable safety profile compared to many other induction methods, with low risk of hyperstimulation.
Despite the widespread knowledge of the importance of women´s labor experience for her future health, this aspect is rarely thoroughly explored in the vast number of studies on labor induction. For outpatient labor induction to work, it must be an alternative women find beneficial, as well as clinicians and the health care system.
Aim
The overall aim of this study is to investigate if outpatient induction of labor is beneficial in a Norwegian setting. This includes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy nulliparous women
- •A single, healthy fetus in cephalic presentation at gestational age of 37 weeks or more
- •Normal pregnancy
- •The woman can read and communicate in Norwegian
- •No cognitive barriers
- •BMI 15,5-39,9
- •Reside within one hour from the hospital
- •Indication for labor induction is post term pregnancy, uncomplicated pre labor rupture of membranes, maternal wish or other indications determined as low-risk by the attending obstetrician
排除标准
- •Known uterine abnormality or previous uterine surgery
- •Major maternal medical illness requiring monitoring of mother or fetus in early labor
- •Maternal infection
- •Pregnancy complications such as preeclampsia, poorly controlled hypertension or medically treated diabetes mellitus
- •Active vaginal bleeding characterized as more than bloody show
- •Non-reassuring cardiotocography or reduced fetal movement
- •Fetal growth EFW < 10th percentile or >90th percentile
- •Poly- or oligohydramnios
- •Known abnormalities in the placenta or umbilical cord
结局指标
主要结局
Deliveries outside the hospital
时间窗: At time of delivery
The proportion of deliveries outside the hospital in the outpatient versus inpatient induction group
The proportion of eligible women selecting outpatient labor induction
时间窗: up to 18 months
Fetal metabolic acidosis
时间窗: From delivery and within two hours postpartum
The proportion of fetal metabolic acidosis
次要结局
- Uterine rupture(During labor induction or birth)
- Need for neonatal resuscitation after delivery(Within two hours after delivery)
- Delivery mode(At the time of delivery)
- Maternal admission to ICU or maternal death(From start of induction through discharge, normally within 2-4 days after delivery)
- Maternal hemorrhage (in ml)(During birth and until two hours after delivery)
- Duration of the stages during induction and birth(From start of induction until transfer top postpartum ward)
- Need for other interventions to induce or augment labor(From start of induction until start of active labor)
- Chorioamnionitis(During birth and until two hours after delivery)
- Uterine tachysystole(From start of induction until delivery)
- Umbilical cord pH and pCO2(Immediately after delivery)
- Misoprostol administration(From start of induction until start of active labor)
- Postnatal depression(6-8 weeks postpartum)
- Indications for operative delivery(At the time of delivery)
- Perinatal death(From start of induction until 1 week after delivery)
- The experience of labor induction(6-8 weeks postpartum)
- The experience of childbirth(6-8 weeks postpartum)
- Perineal injury(At the time of delivery)
- Presence of meconium in amniotic fluid(From start of induction until delivery)
- Admission to NICU due to birth related issues(From delivery until discharge, usually 2-4 days after delivery, maximum of 1 week postpartum)
- Apgar score(1, 5 and 10 minutes after delivery)
- Contact with the hospital during the labor induction process(From start of induction until hospital admission)
- The Early Labor Experience(From start of induction until delivery and 6-8 weeks postpartum)
研究者
Mirjam Lukasse
Professor
Oslo Metropolitan University