AzTrials
AzTrials

Preterm BirthNCT03979196

Inpatient vs Outpatient Management of Short Cervix

A study testing Inpatient Management and Outpatient Management in people with Preterm Birth and Pregnancy, High Risk, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The presence of short cervix during pregnancy is a risk factor for preterm birth though in many cases women will eventually deliver at term or near term. While there are proven treatments such as cerclage and progesterone that can improve pregnancy outcomes, many women are advised to limit their activity, are put on… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Preterm Birth, Pregnancy, High Risk
What is being tested?
Inpatient Management and Outpatient Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesCanada
Study dates
6 Jun 2019to 7 Sep 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

  • Singleton pregnancy between 23 weeks 0 days - 28 weeks 6 days gestational age
  • SC (≤1.5cm) determined by TVS
  • Vaginal progesterone treatment
  • Cervical dilatation of ≤1cm
  • Located within 45 minute drive from recruitment site (Sunnybrook Health Sciences Centre or North York General Hospital)

Who cannot join

  • Multiple pregnancy
  • Preterm premature rupture of membranes (PPROM), vaginal bleeding, infection, high blood pressure (defined as 140/90 mm Hg or higher)
  • Regular uterine contractions or active labour
  • Vaginal bleeding
  • Cervical dilatation of >1cm
  • Fetal anomalies

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Inpatient vs Outpatient Management of Women With Short Cervix: A Randomized Controlled Trial (RCT)

The presence of short cervix during pregnancy is a risk factor for preterm birth though in many cases women will eventually deliver at term or near term.

While there are proven treatments such as cerclage and progesterone that can improve pregnancy outcomes, many women are advised to limit their activity, are put on bed rest, or admitted to hospital for inpatient management. Presently, there is no evidence that hospital admission of women with short cervix is beneficial and prolongs the pregnancy.

The investigators propose to examine whether inpatient management results in comparable outcomes to outpatient management for women with short cervix.

Read the detailed description

Preterm birth, defined as the birth of a baby at less than 37 weeks' gestation, is a significant burden to society that is on the rise. Although many risk factors contribute to preterm birth, a short cervix is a well-established risk factor.The most common management for short cervix in Canada is vaginal progesterone, cervical cerclage, and hospital admission. Evidence suggests that vaginal progesterone and cervical cerclage improve outcomes, but there is very limited research on hospital admission or its efficacy. Due to the increased risk of preterm birth associated with cervical length ≤15 mm, some patients are admitted to hospital for observation even though labour is not imminent. The role of inpatient versus outpatient management is unclear and has not been explored. Hospital admission or modified activity has not been shown to improve pregnancy outcomes however, due to the increased risk of preterm birth, many women with short cervix are admitted for inpatient management.

This project's objective is to examine whether inpatient or outpatient care results in similar pregnancy outcomes for women with short cervix.

This is a multi-centre, non-inferiority randomized controlled trial in women with a singleton pregnancy and isolated short cervix (SC) (≤1.5cm by transvaginal scan (TVS)) at 23-28 weeks at Sunnybrook Health Sciences Centre (SHSC) and North York General Hospital (NYGH), in Toronto, Ontario, Canada. The intervention involves randomizing women to either inpatient or outpatient management and examining whether gestational age at delivery in women with SC (≤1.5cm by TVS) is comparable between arms. The investigators hypothesize that there will be no difference in the preterm birth rate and gestational age at delivery between the two groups.

Being tested
Inpatient Management, Outpatient Management
Keywords
Preterm Birth, Pregnancy, High Risk, Short Cervix
Medical subject headings
Premature Birth

What participants receive

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

  • Inpatient ManagementOther

    Admission for a minimum of three days, administration of betamethasone, and clinical reassessment by obstetrician after three days. After the initial three day admission, further management will be at the discretion of their obstetrician who will continue their care and decide if further admissions are needed.

    Weekly cervical length assessment will be performed until 28 weeks and patient readmission will be decided by their Obstetrician.

    Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected.

  • Outpatient ManagementOther

    Avoid heavy lifting and core exercise, avoid intercourse, weekly assessment of cervical length by ultrasound and administration of betamethasone. Patients will continue with outpatient management for the remainder of their pregnancy with no admission unless the patient develops contractions, PPROM, bleeding, or the cervix is dilated to ≥1cm.

    Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected.

Study groups in NCT03979196
Study groupRoleWhat they receive
Inpatient ManagementActive comparatorWomen in this arm will follow the standard of care for admission to high-risk units at Sunnybrook Health Sciences Centre or North York General Hospital.
Receives: Other: Inpatient Management
Outpatient ManagementActive comparatorWomen in this arm will be encouraged to follow the standard of care established in the high-risk clinics at Sunnybrook Health Sciences Centre or North York General Hospital.
Receives: Other: Outpatient Management

What is being measured

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

  1. Gestational age at delivery

    Measured: At delivery

Secondary outcomes (6)
  1. Betamethasone treatment

    Measured: Before delivery

  2. Magnesium sulphate treatment

    Measured: Before 32 weeks gestation

  3. Intrapartum complications

    Any of the following: cord prolapse, postpartum hemorrhage, or fetal distress

    Measured: During delivery

  4. Mode of delivery

    One of: vaginal delivery, caesarean section, operative delivery

    Measured: At delivery

  5. Patient Quality of Life

    36-Item Short Form Health Survey: 36-item, self-administered survey takes 5 minutes and is designed to measure health on eight multi-item dimensions, including functional status, well-being, and overall evaluation of health.

    Measured: 1 week after randomization

  6. Neonatal morbidity and mortality: composite measure

    A composite of the following: Early-onset sepsis/meningitis (culture proven within first 7 days of life), Significant Intraventricular hemorrhage (IVH) (Grade III/IV, hemorrhagic venous infarct), Periventricular leukomalacia (PVL), Respiratory distress syndrome (RDS) (requiring surfactant and ventilation), Need for high frequency oscillatory ventilation (HFO) on Day 1, Need for inhaled nitric oxide (iNO) on Day 1, Pneumothorax (requiring needle aspiration or chest tube drainage), Chronic lung disease (requiring oxygen at discharge/transfer or at corrected gestational age (CGA) 36 weeks), Death, retinopathy of prematurity(ROP) (>Stage 2), necrotizing enterocolitis (NEC) (finding of pneumatosis, portal vein gas or free peritoneal air on abdominal radiograph), patent ductus arteriosus (PDA) (presence of PDA diagnosed by echocardiography or clinical suspicion treated with medication or surgery)

    Measured: 1-28 days post-delivery

Timeline

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

  1. First posted7 Jun 2019
  2. Study start6 Jun 2019
  3. Primary completion30 Mar 2020
  4. Study completion7 Sep 2021

Why it stopped: Logistical Challenges

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
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03979196
Sponsor's protocol ID
ShortCxTrial
Status last verified
Apr 2024
First submitted
5 Jun 2019
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Menon R. Preterm birth: a global burden on maternal and child health. Pathog Glob Health. 2012 Jul;106(3):139-40. doi: 10.1179/204777312X13462106637729. No abstract available.

    PubMed 23265368
  • Blencowe H, Lee AC, Cousens S, Bahalim A, Narwal R, Zhong N, Chou D, Say L, Modi N, Katz J, Vos T, Marlow N, Lawn JE. Preterm birth-associated neurodevelopmental impairment estimates at regional and global levels for 2010. Pediatr Res. 2013 Dec;74 Suppl 1(Suppl 1):17-34. doi: 10.1038/pr.2013.204.

    PubMed 24366461
  • Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.

    PubMed 22682464
  • Alexander GR, Kogan M, Bader D, Carlo W, Allen M, Mor J. US birth weight/gestational age-specific neonatal mortality: 1995-1997 rates for whites, hispanics, and blacks. Pediatrics. 2003 Jan;111(1):e61-6. doi: 10.1542/peds.111.1.e61.

    PubMed 12509596
  • Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/

    PubMed 20669423
  • Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.

    PubMed 15752534
  • McCormick MC. The contribution of low birth weight to infant mortality and childhood morbidity. N Engl J Med. 1985 Jan 10;312(2):82-90. doi: 10.1056/NEJM198501103120204.

    PubMed 3880598
  • Berkowitz GS, Papiernik E. Epidemiology of preterm birth. Epidemiol Rev. 1993;15(2):414-43. doi: 10.1093/oxfordjournals.epirev.a036128. No abstract available.

    PubMed 8174665
  • Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.

    PubMed 8569824
  • Berghella V, Kuhlman K, Weiner S, Texeira L, Wapner RJ. Cervical funneling: sonographic criteria predictive of preterm delivery. Ultrasound Obstet Gynecol. 1997 Sep;10(3):161-6. doi: 10.1046/j.1469-0705.1997.10030161.x.

    PubMed 9339522
  • Berghella V, Roman A, Daskalakis C, Ness A, Baxter JK. Gestational age at cervical length measurement and incidence of preterm birth. Obstet Gynecol. 2007 Aug;110(2 Pt 1):311-7. doi: 10.1097/01.AOG.0000270112.05025.1d.

    PubMed 17666605
  • Crane JM, Hutchens D. Transvaginal sonographic measurement of cervical length to predict preterm birth in asymptomatic women at increased risk: a systematic review. Ultrasound Obstet Gynecol. 2008 May;31(5):579-87. doi: 10.1002/uog.5323.

    PubMed 18412093
  • Goldenberg RL, Iams JD, Das A, Mercer BM, Meis PJ, Moawad AH, Miodovnik M, VanDorsten JP, Caritis SN, Thurnau GR, Dombrowski MP, Roberts JM, McNellis D. The Preterm Prediction Study: sequential cervical length and fetal fibronectin testing for the prediction of spontaneous preterm birth. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. 2000 Mar;182(3):636-43. doi: 10.1067/mob.2000.104212.

    PubMed 10739521
  • Guzman ER, Walters C, Ananth CV, O'Reilly-Green C, Benito CW, Palermo A, Vintzileos AM. A comparison of sonographic cervical parameters in predicting spontaneous preterm birth in high-risk singleton gestations. Ultrasound Obstet Gynecol. 2001 Sep;18(3):204-10. doi: 10.1046/j.0960-7692.2001.00526.x.

    PubMed 11555447
  • Heath VC, Southall TR, Souka AP, Elisseou A, Nicolaides KH. Cervical length at 23 weeks of gestation: prediction of spontaneous preterm delivery. Ultrasound Obstet Gynecol. 1998 Nov;12(5):312-7. doi: 10.1046/j.1469-0705.1998.12050312.x.

    PubMed 9819868

Questions about this trial

What is this clinical trial studying?

A study testing Inpatient Management and Outpatient Management in people with Preterm Birth and Pregnancy, High Risk, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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 was stopped early (reason given: Logistical Challenges). 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?

Gestational age at delivery (time frame: At delivery). 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 NCT03979196, which also lists 30 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 22 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in