Cervical ShorteningNCT06884761

Routine Activity and Preterm Delivery Risk in Women With a Short Cervix

A study testing Maximal Rest in people with Cervical Shortening, run by Wolfson Medical Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The goal of this clinical trial is to evaluate the effect of routine activity versus rest on the risk of preterm delivery in pregnant women with a short cervix diagnosed between 24 and 34 weeks of gestation. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Cervical Shortening
What is being tested?: Maximal Rest
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteIsrael
Study dates: 15 Jan 2025to 29 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Singleton pregnancies between 24+0 and 34+6 weeks.
Short cervical length (<25 mm) confirmed via transvaginal ultrasound.
No medical contraindications to physical activity.

Who cannot join

Twin pregnancies or higher-order multiples.
Medical indications for reduced mobility (e.g., symphysiolysis, fall risk).
Maternal comorbidities, fetal distress, vaginal bleeding, PPROM, or need for immediate delivery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Israel1 site, 1 recruiting

The Edith Wolfson Medical Center
Holon, 5822012
Eliel Kedar Sade, MD, +972-52-6008068, elielbob@gmail.com
Ornit Cohen, +972-3-5028399, ornitc@wmc.gov.il
Recruiting

Other trials in Israel

About this study

Official title: The Effect of Routine Activity on the Risk for Preterm Delivery in Women With a Short Cervix. A Randomized Control Trial

Does routine activity influence the gestational age at delivery? How does routine activity affect secondary outcomes such as preterm labor, premature rupture of membranes, delivery mode, maternal anxiety, and satisfaction?

Researchers will compare women instructed to maintain routine activity (control group) to women advised to practice maximal rest (intervention group) to see if physical activity impacts preterm birth outcomes.

Participants will:

Wear a smart band to monitor step counts over a two-week period. Be randomized into two groups: one encouraged to maintain routine activity and the other advised to follow strict rest protocols.

Undergo regular follow-ups at a high-risk pregnancy clinic and have their data collected through hospital records and smart band tracking.

This randomized controlled trial will assess gestational age at delivery as the primary outcome, along with secondary maternal and neonatal outcomes, providing insight into the role of physical activity in managing pregnancies complicated by a short cervix.

Conditions: Cervical Shortening
Being tested: Maximal Rest
Keywords: Preterm delivery, Physical activity, cervical shortening, Bed rest, Cervical length, High-risk pregnancy, Randomized controlled trial
Medical subject headings: Premature Birth, Motor Activity

What participants receive

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

Maximal RestBehavioural
Participants in this group are instructed to follow maximal rest protocols. They are advised to avoid strenuous activities, including prolonged standing, lifting heavy objects, or engaging in physically demanding tasks. This group represents the traditional bed rest approach to managing pregnancies with a short cervix.

Study groups in NCT06884761
Study group	Role	What they receive
Maximal Rest	Experimental	Participants in this group are instructed to follow maximal rest protocols. They are advised to avoid strenuous activities, including prolonged standing, lifting heavy objects, or engaging in physically demanding tasks. This group represents the traditional bed rest approach to managing pregnancies with a short cervix. Receives: Behavioral: Maximal Rest
Routine Activity	No intervention	Participants in this group are encouraged to maintain routine, non-strenuous physical activity. They are not instructed to follow bed rest but are asked to avoid overtly strenuous activities. This group reflects the standard approach of allowing typical daily activity without additional restrictions.

What is being measured

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

gestational age at delivery
to assess the effect of physical activity on the gestational age at delivery.
Measured: two years

Secondary outcomes (3)

Rates of preterm labor.
Measured: two years
Incidence of premature rupture of membranes (PPROM).
Measured: two years
Mod of delivery (cesarean, instrumental, or spontaneous).
Measured: two years

Timeline

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

15 Jan 202529 Dec 2027

First posted19 Mar 2025
Study start15 Jan 2025
Primary completion29 Dec 2027 (estimated)
Study completion29 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Cervical ShorteningStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06884761
Sponsor's protocol ID: 124-24-WOMC
Status last verified: Apr 2025
First submitted: 12 Mar 2025
Last updated: 17 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zemet R, Schiff E, Manovitch Z, Cahan T, Yoeli-Ullman R, Brandt B, Hendler I, Dorfman-Margolis L, Yinon Y, Sivan E, Mazaki-Tovi S. Quantitative assessment of physical activity in pregnant women with sonographic short cervix and the risk for preterm delivery: A prospective pilot study. PLoS One. 2018 Jun 11;13(6):e0198949. doi: 10.1371/journal.pone.0198949. eCollection 2018.
PubMed 29889906
Grobman WA, Gilbert SA, Iams JD, Spong CY, Saade G, Mercer BM, Tita ATN, Rouse DJ, Sorokin Y, Leveno KJ, Tolosa JE, Thorp JM, Caritis SN, Peter Van Dorsten J; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Activity restriction among women with a short cervix. Obstet Gynecol. 2013 Jun;121(6):1181-1186. doi: 10.1097/AOG.0b013e3182917529.
PubMed 23812450
Sosa CG, Althabe F, Belizan JM, Bergel E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane Database Syst Rev. 2015 Mar 30;2015(3):CD003581. doi: 10.1002/14651858.CD003581.pub3.
PubMed 25821121
Teitelman AM, Welch LS, Hellenbrand KG, Bracken MB. Effect of maternal work activity on preterm birth and low birth weight. Am J Epidemiol. 1990 Jan;131(1):104-13. doi: 10.1093/oxfordjournals.aje.a115463.
PubMed 2293743
Maloni JA. Antepartum bed rest for pregnancy complications: efficacy and safety for preventing preterm birth. Biol Res Nurs. 2010 Oct;12(2):106-24. doi: 10.1177/1099800410375978.
PubMed 20798159
Goldenberg RL, Cliver SP, Bronstein J, Cutter GR, Andrews WW, Mennemeyer ST. Bed rest in pregnancy. Obstet Gynecol. 1994 Jul;84(1):131-6.
PubMed 8008308
Berghella V, Saccone G. Cervical assessment by ultrasound for preventing preterm delivery. Cochrane Database Syst Rev. 2019 Sep 25;9(9):CD007235. doi: 10.1002/14651858.CD007235.pub4.
PubMed 31553800
Navathe R, Saccone G, Villani M, Knapp J, Cruz Y, Boelig R, Roman A, Berghella V. Decrease in the incidence of threatened preterm labor after implementation of transvaginal ultrasound cervical length universal screening. J Matern Fetal Neonatal Med. 2019 Jun;32(11):1853-1858. doi: 10.1080/14767058.2017.1421166. Epub 2018 Jan 5.
PubMed 29303014
Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
PubMed 24625129
Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
PubMed 20732945
MacDorman MF, Kirmeyer S. Fetal and perinatal mortality, United States, 2005. Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19.
PubMed 19294965
Hamilton BE, Martin JA, Osterman MJ. Births: Preliminary Data for 2015. Natl Vital Stat Rep. 2016 Jun;65(3):1-15.
PubMed 27309256
Society for Maternal-Fetal Medicine Publications Committee, with assistance of Vincenzo Berghella. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012 May;206(5):376-86. doi: 10.1016/j.ajog.2012.03.010.
PubMed 22542113
WHO: recommended definitions, terminology and format for statistical tables related to the perinatal period and use of a new certificate for cause of perinatal deaths. Modifications recommended by FIGO as amended October 14, 1976. Acta Obstet Gynecol Scand. 1977;56(3):247-53. No abstract available.
PubMed 560099

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cervical Shortening trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Routine Activity on the Risk for Preterm Delivery in Women With a Short Cervix. A Randomized Control Trial
ClinicalTrials.gov ID: NCT06884761
Acronym / sponsor ID: 124-24-WOMC
Conditions: Cervical Shortening
Keywords: Preterm delivery, Physical activity, cervical shortening, Bed rest, Cervical length, High-risk pregnancy, Randomized controlled trial
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Wolfson Medical CenterOther government
Study start: 15 Jan 2025 (actual)
Primary completion: 29 Dec 2027 (estimated)
Study completion: 29 Dec 2027 (estimated)
First posted: 19 Mar 2025 (actual)
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.

Participants will:

Wear a smart band to monitor step counts over a two-week period. Be randomized into two groups: one encouraged to maintain routine activity and the other advised to follow strict rest protocols.

Undergo regular follow-ups at a high-risk pregnancy clinic and have their data collected through hospital records and smart band tracking.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Maximal Rest	Experimental	Behavioral: Maximal RestParticipants in this group are instructed to follow maximal rest protocols. They are advised to avoid strenuous activities, including prolonged standing, lifting heavy objects, or engaging in physically demanding tasks. This group represents the traditional bed rest approach to managing pregnancies with a short cervix.
Routine Activity	No intervention	–Participants in this group are encouraged to maintain routine, non-strenuous physical activity. They are not instructed to follow bed rest but are asked to avoid overtly strenuous activities. This group reflects the standard approach of allowing typical daily activity without additional restrictions.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Singleton pregnancies between 24+0 and 34+6 weeks.
Short cervical length (<25 mm) confirmed via transvaginal ultrasound.
No medical contraindications to physical activity.

Key exclusion criteria (3 listed)

Twin pregnancies or higher-order multiples.
Medical indications for reduced mobility (e.g., symphysiolysis, fall risk).
Maternal comorbidities, fetal distress, vaginal bleeding, PPROM, or need for immediate delivery.

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
Maximal RestParticipants in this group are instructed to follow maximal rest protocols. They are advised to avoid strenuous activities, including prolonged standing, lifting heavy objects, or engaging in physically demanding tasks. This group represents the traditional bed rest approach to managing pregnancies with a short cervix.	Behavioural	Maximal Rest

Primary outcome

gestational age at delivery
Time frame: two years
to assess the effect of physical activity on the gestational age at delivery.

3 secondary outcomes

Rates of preterm labor.
Time frame: two years
Incidence of premature rupture of membranes (PPROM).
Time frame: two years
Mod of delivery (cesarean, instrumental, or spontaneous).
Time frame: two years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Results publication: PubMed 29889906Zemet R, Schiff E, Manovitch Z, Cahan T, Yoeli-Ullman R, Brandt B, Hendler I, Dorfman-Margolis L, Yinon Y, Sivan E, Mazaki-Tovi S. Quantitative assessment of physical activity in pregnant women with sonographic short cervix and the risk for preterm delivery: A prospective pilot study. PLoS One. 2018 Jun 11;13(6):e0198949. doi: 10.1371/journal.pone.0198949. eCollection 2018.
Results publication: PubMed 23812450Grobman WA, Gilbert SA, Iams JD, Spong CY, Saade G, Mercer BM, Tita ATN, Rouse DJ, Sorokin Y, Leveno KJ, Tolosa JE, Thorp JM, Caritis SN, Peter Van Dorsten J; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Activity restriction among women with a short cervix. Obstet Gynecol. 2013 Jun;121(6):1181-1186. doi: 10.1097/AOG.0b013e3182917529.
Results publication: PubMed 25821121Sosa CG, Althabe F, Belizan JM, Bergel E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane Database Syst Rev. 2015 Mar 30;2015(3):CD003581. doi: 10.1002/14651858.CD003581.pub3.
Results publication: PubMed 2293743Teitelman AM, Welch LS, Hellenbrand KG, Bracken MB. Effect of maternal work activity on preterm birth and low birth weight. Am J Epidemiol. 1990 Jan;131(1):104-13. doi: 10.1093/oxfordjournals.aje.a115463.
Results publication: PubMed 20798159Maloni JA. Antepartum bed rest for pregnancy complications: efficacy and safety for preventing preterm birth. Biol Res Nurs. 2010 Oct;12(2):106-24. doi: 10.1177/1099800410375978.
Results publication: PubMed 8008308Goldenberg RL, Cliver SP, Bronstein J, Cutter GR, Andrews WW, Mennemeyer ST. Bed rest in pregnancy. Obstet Gynecol. 1994 Jul;84(1):131-6.
Results publication: PubMed 31553800Berghella V, Saccone G. Cervical assessment by ultrasound for preventing preterm delivery. Cochrane Database Syst Rev. 2019 Sep 25;9(9):CD007235. doi: 10.1002/14651858.CD007235.pub4.
Results publication: PubMed 29303014Navathe R, Saccone G, Villani M, Knapp J, Cruz Y, Boelig R, Roman A, Berghella V. Decrease in the incidence of threatened preterm labor after implementation of transvaginal ultrasound cervical length universal screening. J Matern Fetal Neonatal Med. 2019 Jun;32(11):1853-1858. doi: 10.1080/14767058.2017.1421166. Epub 2018 Jan 5.
Results publication: PubMed 24625129Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
Results publication: PubMed 20732945Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
Results publication: PubMed 19294965MacDorman MF, Kirmeyer S. Fetal and perinatal mortality, United States, 2005. Natl Vital Stat Rep. 2009 Jan 28;57(8):1-19.
Results publication: PubMed 27309256Hamilton BE, Martin JA, Osterman MJ. Births: Preliminary Data for 2015. Natl Vital Stat Rep. 2016 Jun;65(3):1-15.
Individual participant dataSharing planned: No

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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.

The Edith Wolfson Medical Center

Holon, Israel

+972-52-6008068

elielbob@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Maximal Rest in people with Cervical Shortening, run by Wolfson Medical Center at 1 site in Israel.

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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Apr 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 Israel. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gestational age at delivery (time frame: two years). 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 NCT06884761, which also lists 14 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 17 Apr 2025.