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| ID | Type | Description | Link |
|---|---|---|---|
| 2007/65-31/2 | Other Identifier | EPN Stockholm |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early induction | Active Comparator | Induction was performed if membranes were still intact and cervical dilation was less than four centimetres five hours after medication for therapeutic rest. For participants with an unripe cervix intravaginal prostaglandin E2 (PgE2, dinoproston) was used. A transcervical catheter (BARD) was inserted if this procedure was possible 19 and if cervical dilatation permitted, amniotomy was performed. The physician in charge performed all assessments and procedures except amniotomy. When the participants reached the active phase they were monitored according to the clinical guidelines. |
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| expectant management | Experimental | The participants in the control group awaited spontaneous onset of labour as long as possible (expectant management). If contractions had ceased or subsided after the therapeutic rest women could be discharged from hospital, but were still included in the study. When reaching the active phase of labour women were monitored according to the clinical guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early induction | Other |
| ||
| Expectant mamagement |
| Measure | Description | Time 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Women had to be able to read, understand and speak Swedish.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Förlossningen, Danderyd Hospital | Stockholm | Stockholm County | 182 88 | Sweden |
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| 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. |
| 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. |