Förlossningen, Danderyd Hospital
Stockholm, Stockholm County, 182 88, Sweden
Completed
NCT Number: NCT01863797
Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase
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.
Completed
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Notify MeKey information
Age range
16 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Early induction
OtherExpectant mamagement
OtherPrimary outcomes
-
The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes
-
Maternal outcome measure included experience of delivery
Time frame: Experience of delivery was assessed two days after 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.
Other outcomes
-
Maternal outcome measures included duration of labour, labour analgesia, intrapartum exogenous oxytocin stimulation, partum haemorrhage, number of sphincter tears.
Time frame: 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.
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.
-
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
Time frame: Neonatal outcomes were measured from delivery and until two days after delivery.
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.
Sponsors and collaborators
Lead sponsor
Karolinska Institutet
Other
Registry information
Important dates
- Study start
- 2007
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 29, 2013
- Registry last updated
- May 29, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.