Arabin Pessary Combine With Vaginal Progesterone Compare With Vaginal Progesterone Alone to Prevent Preterm Delivery in Singleton Pregnancies

NCT03052270 | Terminated Phase 3 FDA Drug

• 1 other identifier: 2016-0599
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.This will be a randomized prospective and open-label study with no placebo control or blinding of the participants and the research team members. The study is to compare the effectiveness of vaginal progesterone versus combination of vaginal progesterone and Arabin cervical pessary in the prevention of preterm delivery among patients with incidental shortened cervical length.
2. 2.As part of standard clinical care, all pregnant patients usually have cervical length measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the GE ultrasound Volusion 8 using the vaginal probe.
3. 3.Patients with short cervix will be counseled and offered the opportunity to participate in the study.
4. 4.All participants will be taught how to use the vaginal progesterone once daily prior to bedtime. In addition, those in the combination group will have the cervical pessary placed in the clinic right away or within a week if they request for more time to brood over their diagnosis and weigh on the option of inserting Arabin pessary.
5. 5.All participants will be followed up in the high-risk obstetric clinic as per standard prenatal care. Frequency of follow up visits will be individualized depending on patient's need and comorbidities. , Participants will be requested to bring the remnant of the vaginal progesterone to the clinic to assess compliance.
6. 6.Participants in the study will continue their prenatal care with UIC high-risk obstetric clinic until delivery.
7. 7.The study recruitment will occur for a period of 2 years starting from November 2016 to October 2018 or until all the anticipated numbers of study subjects have been attained.
8. 8.There will be 10 % over-sampling to cater for those who will drop out from the study or loss to follow up after randomization, and those who delivered in another hospital.
9. 9.Participants will have access to one of the investigators or the high- risk clinic nurse for any complaints related to their conditions.
10. 10.Participants can opt out at any stage of the study if they do not want to continue further or if there are any adverse effects.

Conditions

Focus: Prevent Preterm Delivery; Incidental Short Cervix at Mid-trimester

Outcome Measures

Primary Outcomes (1)

• Preterm delivery before 37 weeks

  1\. To compare the effectiveness of the combination of vaginal progesterone and Arabin pessary in the prevention of preterm delivery prior to 37 weeks compared to vaginal progesterone alone.

  2 years

Secondary Outcomes (3)

• Preterm delivery before 28 weeks

  2 years

• Preterm delivery before 32 weeks

  2 years

• Preterm delivery before 34 weeks

  2 years

Study Arms (2)

Vaginal progesterone and Pessary

EXPERIMENTAL

1. Short cervical length equal or less than 20 mm 2. Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries. 3. 18 years or older at the time of enrollment. 4. Consent to participate in the study Vaginal progesterone as standard of care plus Arabin pessary

Drug: Arabin Pessary

Vaginal progesterone only

ACTIVE COMPARATOR

1. Short cervical length equal or less than 20 mm 2. Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries. 3. 18 years or older at the time of enrollment. 4. Consent to participate in the study Vaginal progesterone as standard of care

Drug: Arabin Pessary

Interventions

Arabin Pessary DRUG

Insertion of Arabin pessary for the prevention of preterm delivery

Vaginal progesterone and Pessary; Vaginal progesterone only

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Short cervical length equal or less than 20 mm
• Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries.
• years or older at the time of enrollment.
• Consent to participate in the study

You may not qualify if:

• Previous preterm delivery less than 37 weeks
• Major fetal anomalies
• Multiple pregnancy
• Patient currently with cervical cerclage in-situ for the treatment of incompetence cervix.
• Regular uterine contractions or significantly dilated cervical canal
• Age less than 18 years
• Decline to participate in the study

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.

  PMID: 36453699 DERIVED

Study Officials

• Mary D Stephenson, MD, MSc

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Model Details: Randomization between two arms: short cervix with vaginal progesterone and Arabin pessary (study group) versus short cervix with vaginal progesterone alone (control group)

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: January 1, 2017
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)