Nulliparous Women With Prolonged Latent PhaseNCT01863797
Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase
A study testing Early induction and Expectant mamagement in people with Nulliparous Women With Prolonged Latent Phase, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Nulliparous Women With Prolonged Latent Phase
- What is being tested?
- Early induction and Expectant mamagement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2007to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Förlossningen, Danderyd Hospital
Stockholm, Stockholm County, 182 88
About this study
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.
- Being tested
- Early induction, Expectant mamagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early inductionOther
Expectant mamagementOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Early induction |
| 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. Receives: Other: Expectant mamagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (1)
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.
Measured: Experience of delivery was assessed two days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startJun 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nulliparous Women With Prolonged Latent PhaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Bräne, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863797
- Sponsor's protocol ID
- EPN 2007/65-31/2
- Other IDs
- 2007/65-31/2
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase
- ClinicalTrials.gov ID
- NCT01863797
- Acronym / sponsor ID
- EPN 2007/65-31/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early induction | Active comparator | Other: Early inductionInduction 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. |
| expectant management | Experimental | Other: Expectant mamagementThe 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early induction | Other | Early induction |
| Expectant mamagement | Other | expectant management |
Primary outcome
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
1 secondary outcome
Maternal outcome measure included experience of delivery
Time frame: Experience of delivery was assessed two days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early induction and Expectant mamagement in people with Nulliparous Women With Prolonged Latent Phase, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.