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Active Second StagePASSTNCT03018860

Alternative to Intensive Management of the Active Phase of the Second Stage of Labor

A study testing "Moderate" management and "Intensive" management in people with Active Second Stage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Active Second Stage
What is being tested?
"Moderate" management and "Intensive" management
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,701 participants
Where
1 siteFrance
Study dates
25 Jan 2017to 7 Dec 2021
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • primiparous women
  • singleton fetus
  • fetal cephalic presentation
  • ≥37 gestational weeks
  • living fetus
  • Patient with epidural analgesia
  • Major Female
  • Women understand French

Who cannot join

  • Abnormal fetal heart rate requiring hastening childbirth
  • cervical dilatation < 8 cm
  • intrauterine fetal growth restriction <5e percentile,
  • Fetal malformation,
  • history of gynecological surgery with uterine scar
  • Women do not understand French,
Show all 9Show fewer
  • women with psychiatric condition
  • contraindication to intensive management of active second stage (severe myopia, respiratory or cardiac failure)
  • no affiliation to a social security scheme (beneficiary or assignee)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Cochin Hospital

    Paris, Paris, 75014

Other trials in France

About this study

Official title: Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial

Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery.

Read the detailed description

Management of the active phase of the second stage of labor is not an evidence-based practice. Management of this phase differs between countries. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.

This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery. In the intervention group, i.e. "moderate" pushing, women are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.

The hypothesis is that "moderate" management of the active phase of the second stage allows decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative delivery and increasing maternal satisfaction.

Being tested
"Moderate" management, "Intensive" management
Keywords
Active second stage, Neonatal morbidity, Operative delivery, Labor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Moderate" managementProcedure or surgery

    After randomization, women allocated to the intervention group, i.e. "moderate" pushing, are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.

  • "Intensive" managementProcedure or surgery

    This group corresponds to usual obstetrical management of active second stage in France. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.

Study groups in NCT03018860
Study groupRoleWhat they receive
"Moderate" managementExperimentalWomen are encouraged by physicians to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.
Receives: Procedure: "Moderate" management
"Intensive" managementActive comparatorUsual obstetrical care in France
Receives: Procedure: "Intensive" management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal morbidity composite measure

    number of participant with acidosis arterial cord pH <7.15 and / or excess base> 10 mmol / L and / or lactate> 6 mmol / L and or an Apgar score at 5 minutes <7 and or severe neonatal trauma defined by fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure) and or an Apgar score at 5 minutes <7 and or severe neonatal trauma: fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure)

    Measured: at childbirth

Secondary outcomes (9)

  1. Mode of delivery

    spontaneous vaginal, instrumental vaginal delivery or cesarean section

    Measured: at childbirth

  2. Immediate postpartum complications

    Perineal lesions with involvement of the anal sphincter (3rd and 4th degree)

    Measured: 2 hours after delivery

  3. Immediate postpartum complications

    Episiotomy

    Measured: 2 hours after delivery

  4. Immediate postpartum complications

    Cervical and vaginal lesion

    Measured: 2 hours after delivery

  5. Immediate postpartum complications

    Severe postpartum hemorrhage (blood loss estimated> 1000 mL, using sulprostone, intrauterine bloating, transfusion, uterine artery embolization, vessel ligation, uterine upholstery, of hysterectomy)

    Measured: 2 hours after delivery

  6. Immediate postpartum complications

    Postpartum Hemorrhage (blood loss estimated> 500mLand < 1000mL)

    Measured: 2 hours after delivery

  7. Women satisfaction assessed with the Labour Agentry scale

    Measured: 2 hours after delivery

  8. Women satisfaction assessed with the ICIQ-UI Short Form

    Measured: 6 months post partum

  9. Urinary and anal incontinence assessed with the Wexner Score

    Measured: 6 months post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study start25 Jan 2017
  3. Primary completion25 Mar 2021
  4. Study completion7 Dec 2021

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,701 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018860
Sponsor's protocol ID
P150937
Acronym
PASST
Status last verified
Aug 2025
First submitted
3 Jan 2017
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Le Ray C, Audibert F. [Duration of pushing in labor: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2008 Jun;37(4):325-8. doi: 10.1016/j.jgyn.2008.02.009. Epub 2008 Apr 10. French.

    PubMed 18406074

  • Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8. doi: 10.1111/j.1471-0528.2001.00034.x.

    PubMed 11281466

  • Le Ray C, Audibert F, Goffinet F, Fraser W. When to stop pushing: effects of duration of second-stage expulsion efforts on maternal and neonatal outcomes in nulliparous women with epidural analgesia. Am J Obstet Gynecol. 2009 Oct;201(4):361.e1-7. doi: 10.1016/j.ajog.2009.08.002.

    PubMed 19788968

  • Cheng YW, Hopkins LM, Caughey AB. How long is too long: Does a prolonged second stage of labor in nulliparous women affect maternal and neonatal outcomes? Am J Obstet Gynecol. 2004 Sep;191(3):933-8. doi: 10.1016/j.ajog.2004.05.044.

    PubMed 15467567

  • Dionne MD, Deneux-Tharaux C, Dupont C, Basso O, Rudigoz RC, Bouvier-Colle MH, Le Ray C. Duration of Expulsive Efforts and Risk of Postpartum Hemorrhage in Nulliparous Women: A Population-Based Study. PLoS One. 2015 Nov 10;10(11):e0142171. doi: 10.1371/journal.pone.0142171. eCollection 2015.

    PubMed 26555447

  • Le Ray C, Rozenberg P, Kayem G, Harvey T, Sibiude J, Doret M, Parant O, Fuchs F, Vardon D, Azria E, Senat MV, Ceccaldi PF, Seco A, Garabedian C, Chantry AA; Groupe de Recherche en Obstetrique et Gynecologie. Alternative to intensive management of the active phase of the second stage of labor: a multicenter randomized trial (Phase Active du Second STade trial) among nulliparous women with an epidural. Am J Obstet Gynecol. 2022 Oct;227(4):639.e1-639.e15. doi: 10.1016/j.ajog.2022.07.025. Epub 2022 Jul 19.

    PubMed 35868416

  • Dupuis N, Pizzoferrato AC, Garabedian C, Rozenberg P, Kayem G, Harvey T, Mandelbrot L, Doret M, Fuchs F, Azria E, Senat MV, Ceccaldi PF, Seco A, Chantry A, Le Ray C; GROG (Groupe de Recherche en Obstetrique et Gynecologie). Moderate or intensive management of the active phase of second-stage labor and risk of urinary and anal incontinence: results of the PASST randomized controlled trial. Am J Obstet Gynecol. 2023 Nov;229(5):528.e1-528.e17. doi: 10.1016/j.ajog.2023.07.034. Epub 2023 Jul 26.

    PubMed 37499991

Questions about this trial

What is this clinical trial studying?

A study testing "Moderate" management and "Intensive" management in people with Active Second Stage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 8 inclusion and 9 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 5 Sep 2025. 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 France. 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?

Neonatal morbidity composite measure (time frame: at childbirth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03018860, which also lists 7 linked publications.

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 5 Sep 2025.

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