Nulliparous Women With Prolonged Latent Phase Clinical Trial
| Verified date | May 2013 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Swedish National Council on Medical Ethics |
| Study type | Interventional |
The purpose of the study was to compare early induction versus expectant management regarding outcome and experience of delivery in nulliparous women with a prolonged latent phase.
| Status | Completed |
| Enrollment | 138 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 16 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - generally healthy nulliparous women and normal pregnancies (in vitro-fertilisation included) - with a singleton fetus in cephalic presentation, - gestational age between 37+0 and 41+6, - continuous contractions exceeding 18 hours impeding rest (women's report), - a cervical dilation of less than four centimetres and intact membranes. Gestational age was confirmed by ultrasound in the first trimester. Women had to be able to read, understand and speak Swedish. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Förlossningen, Danderyd Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Maternal outcome measures included duration of labour, labour analgesia, intrapartum exogenous oxytocin stimulation, partum haemorrhage, number of sphincter tears. | Duration of labour was measured in hours from cervical dilatation of four cm until delivery. Only the most active analgesia was recorded during active delivery (from cervical dilatation of four cm until delivery). Intrapartum exogenous oxytocin stimulation during active labour was recorded (yes or no). Post partum hemorrhage was measured from delivery and until two hours after delivery. | Duration of labour, labour analgesia, intrapartum exogenous oxytocin stimulation were measured from cervical dilatation of 4 cm until delivery. Post partum hemorrhage was measured two hours after delivery. Sphincter tear measure directly after delivery. | No |
| Other | Neonatal outcomes; birth presentation, Apgar score below 7 and cord artery metabolic acidosis, admission to neonatal intensive care (NICU), birth weight and child's head circumference | Birth presentation was assessed at delivery. Apgar score was assessed five minutes after delivery and cord artery metabolic acidosis assessed at delivery. Admission to NICU was measured from delivery and until two days after delivery. Birth weight and child's head circumference was measured in average two hours after delivery. | Neonatal outcomes were measured from delivery and until two days after delivery. | No |
| Primary | The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental)) | Participants will be followed for the duration of hospital stay, an expected average of 3 days | No | |
| Secondary | Maternal outcome measure included experience of delivery | Wijma Delivery Experience Questionnaire - validated instrument. The 33 question questionnaire was filled in by the participance two days after delivery at postnatal care unit or at home. | Experience of delivery was assessed two days after delivery | No |