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DystociaSLiPNCT02486822

Labor Scale Versus WHO Partograph in the Management of Labor

A study testing Amniotomy, Oxytocin and Cesarean Section in people with Dystocia, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to compare the novel labour scale with the traditional WHO partograph in the management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Dystocia
What is being tested?
Amniotomy, Oxytocin and Cesarean Section
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteEgypt
Study dates
Jul 2015to Jun 2016
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 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Primigravida
  • 38 - 42 weeks of gestation
  • Singleton pregnancy
  • Vertex presentation
  • Spontaneous labour
  • Average estimated fetal weight (2500 - 3800 gram)

Who cannot join

  • Maternal medical or surgical major co-morbidity
  • Previous uterine scar
  • Induction of labor
  • Premature rupture of membranes

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut Faculty of Medicine - Women Health Hospital

    Asyut, 71515

Other trials in Egypt

About this study

Official title: The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph

This study aims to compare the novel labour scale with the traditional WHO partograph in the management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes

Read the detailed description

After many centuries through which vaginal delivery (VD) had been the only safe route of birth, Cesarean section (CS) emerged as an alternative in emergency situations. CS has gradually become an appealing option for both the mother and the obstetrician and its indications increase while CS was proving safety; the rate of CS in U.S.A increased by about 50% within 10 years around the beginning of the current century. However, the increasing prevalence of CS raises questions about the impact of this trend on maternal morbidity, mortality as well as its economic burden. Accordingly, recent guidelines have been directed to revise practice-base CS indications to only situations when CS is truly beneficial to the mother and/or the fetus.

Of these indications, the most reported one was labour dystocia. The WHO partograph is a famous chart that is commonly used to observe uncomplicated labour and is almost an objective approach to guide interference. Unfortunately, the rule of the partograph in reducing the incidence of CS is questionable. Furthermore, the design of the partograph is not exactly perfect to present the process of labour. For these reasons, the labour scale was designed as a novel follow-up chart during labour. The chart considered more objective and timed management of labour with more flexible range of time based on recent evidence. A previous pilot study on 77 women suggested that the labour scale may be a good alternative to the current partograph. This study is the first randomized trial the compares the 2 charts as regards the rate of CS, maternal and neonatal health outcomes and both patient and obstetrician satisfaction.

In this clinical trial, the investigators aim to compare the labour scale to the traditional WHO partograph in terms of incidence of labor dystocia and CS as well as maternal and neonatal outcomes

Conditions
Dystocia
Being tested
Amniotomy, Oxytocin, Cesarean Section
Keywords
Labor scale, Partograph, Spontaneous labor, Primigravida
Medical subject headings
Dystocia

What participants receive

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

  • AmniotomyProcedure or surgery

    Also called Artificial rupture of membranes

    Amniotomy, artificial rupture of membranes, is done with initial delay of labor (in partograph: extension beyond alert line, in labor scale: when progress reaches the membrane line)

  • OxytocinDrug

    Also called augmentation of labor

    Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)

  • Cesarean SectionProcedure or surgery

    Also called CS

    Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)

Study groups in NCT02486822
Study groupRoleWhat they receive
Labor scaleExperimentalObservation Amniotomy Oxytocin Cesarean Section (CS)
Receives: Procedure: Amniotomy; Drug: Oxytocin; Procedure: Cesarean Section
WHO partographActive comparatorObservation Amniotomy Oxytocin Cesarean Section (CS)
Receives: Procedure: Amniotomy; Drug: Oxytocin; Procedure: Cesarean Section

What is being measured

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

  1. Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)

    The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia

    Measured: Time of labor (maximum 24 hours)

Secondary outcomes (7)

  1. Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)

    Measured: Time of labor (maximum 24 hours)

  2. Intrapartum maternal birth injuries (assessed clinically at the time of labor, the extent and type of repair and subsequent complications will be reported)

    Measured: Time of labour and hospital stay (expected average 72 hours)

  3. Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions

    Measured: The length of hospital stay (expected average 72 hours)

  4. Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture

    Measured: The length of hospital stay (expected average 72 hours)

  5. Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring

    Measured: Duration of labor (maximum 24 hours)

  6. birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management )

    Measured: The length of hospital stay (expected average 1 week)

  7. Neonatal distress "asphyxia" (as reported 1 & 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to NICU, length of stay and any further medical complications)

    Measured: The length of hospital/NICU stay (expected average 1 week)

Timeline

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

  1. First posted1 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2016 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02486822
Sponsor's protocol ID
IRB00008718 - SLiP
Acronym
SLiP
Status last verified
May 2016
First submitted
24 Jun 2015
Last updated
11 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Shazly SA, Embaby LH, Ali SS. The labour scale--assessment of the validity of a novel labour chart: a pilot study. Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):322-6. doi: 10.1111/ajo.12209. Epub 2014 May 17.

    PubMed 24835694

  • Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.

    PubMed 20334736

  • Villar J, Valladares E, Wojdyla D, Zavaleta N, Carroli G, Velazco A, Shah A, Campodonico L, Bataglia V, Faundes A, Langer A, Narvaez A, Donner A, Romero M, Reynoso S, de Padua KS, Giordano D, Kublickas M, Acosta A; WHO 2005 global survey on maternal and perinatal health research group. Caesarean delivery rates and pregnancy outcomes: the 2005 WHO global survey on maternal and perinatal health in Latin America. Lancet. 2006 Jun 3;367(9525):1819-29. doi: 10.1016/S0140-6736(06)68704-7.

    PubMed 16753484

  • Liu S, Liston RM, Joseph KS, Heaman M, Sauve R, Kramer MS; Maternal Health Study Group of the Canadian Perinatal Surveillance System. Maternal mortality and severe morbidity associated with low-risk planned cesarean delivery versus planned vaginal delivery at term. CMAJ. 2007 Feb 13;176(4):455-60. doi: 10.1503/cmaj.060870.

    PubMed 17296957

  • Kjaergaard H, Olsen J, Ottesen B, Dykes AK. Incidence and outcomes of dystocia in the active phase of labor in term nulliparous women with spontaneous labor onset. Acta Obstet Gynecol Scand. 2009;88(4):402-7. doi: 10.1080/00016340902811001.

    PubMed 19330572

  • Gifford DS, Morton SC, Fiske M, Keesey J, Keeler E, Kahn KL. Lack of progress in labor as a reason for cesarean. Obstet Gynecol. 2000 Apr;95(4):589-95. doi: 10.1016/s0029-7844(99)00575-x.

    PubMed 10725495

  • Lavender T, Hart A, Smyth RM. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD005461. doi: 10.1002/14651858.CD005461.pub2.

    PubMed 18843690

  • National Collaborating Centre for Women's and Children's Health (UK). Intrapartum Care: Care of Healthy Women and Their Babies During Childbirth. London: RCOG Press; 2007 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK49388/

    PubMed 21250397

  • Amer-Wahlin I, Hellsten C, Noren H, Hagberg H, Herbst A, Kjellmer I, Lilja H, Lindoff C, Mansson M, Martensson L, Olofsson P, Sundstrom A, Marsal K. Cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram for intrapartum fetal monitoring: a Swedish randomised controlled trial. Lancet. 2001 Aug 18;358(9281):534-8. doi: 10.1016/s0140-6736(01)05703-8.

    PubMed 11520523

  • Tolba SM, Ali SS, Mohammed AM, Michael AK, Abbas AM, Nassr AA, Shazly SA. Management of Spontaneous Labor in Primigravidae: Labor Scale versus WHO Partograph (SLiP Trial) Randomized Controlled Trial. Am J Perinatol. 2018 Jan;35(1):48-54. doi: 10.1055/s-0037-1605575. Epub 2017 Aug 8.

    PubMed 28787749

Questions about this trial

What is this clinical trial studying?

A study testing Amniotomy, Oxytocin and Cesarean Section in people with Dystocia, run by Assiut University at 1 site in Egypt.

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 4 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: status not confirmed, as of the sponsor's last update on 11 May 2016. 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 Egypt. 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?

Results are not available in the source record.

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?

Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported) (time frame: Time of labor (maximum 24 hours)). 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 NCT02486822, which also lists 10 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 11 May 2016.

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