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Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01863797
Enrollment
138
Registered
2013-05-29
Start date
2007-06-30
Completion date
2012-05-31
Last updated
2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nulliparous Women With Prolonged Latent Phase

Brief summary

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.

Interventions

OTHEREarly induction
OTHERExpectant mamagement

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frameDescription
Maternal outcome measure included experience of deliveryExperience of delivery was assessed two days after deliveryWijma 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

MeasureTime frameDescription
Maternal outcome measures included duration of labour, labour analgesia, intrapartum exogenous oxytocin stimulation, partum haemorrhage, number of sphincter tears.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 circumferenceNeonatal 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026