Trial · NCT02518594
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
NCT02518594, Phase 3, Completed, The George Washington University Biostatistics Center; results first posted 2026-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix. Trials, record NCT02518594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02518594
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
- NCT number
- NCT02518594
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,311 participants, actual
- Lead sponsor
- The George Washington University Biostatistics Center
- Conditions
- Short Cervical Length
- Interventions
- Vaginal progesterone, Placebo, Arabin Pessary
- First posted
- 2015-08-10
- Last updated
- 2026-06-25
- Results first posted
- 2026-03-10
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation | From randomization to 35 weeks gestation (a period of up to 19 weeks) | Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation |
| Secondary | Days From Randomization to Delivery (or Fetal Demise) | Randomization to delivery (a period of up to 26 weeks) | Days from the time of randomization (16-23 weeks gestation) to delivery or death of the fetus. |
| Secondary | Gestational Age at Delivery or Fetal Death | Randomization to delivery (a period of up to 26 weeks) | Gestational age at the time of delivery or death |
| Secondary | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation | From randomization to up to 28 weeks gestation (a period if up to 12 weeks) | Preterm delivery or fetal loss of either twin prior to 28 weeks gestation |
| Secondary | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation | From randomization to 32 weeks gestation (a period of up to 16 weeks) | Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation |
| Secondary | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation | randomization to 37 weeks gestation (a period of up to 21 weeks) | Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation |
| Secondary | Number of Participants With Spontaneous Preterm Delivery < 32 Weeks Gestation | randomization to 32 weeks gestation (a period of up to 16 weeks) | Spontaneous preterm delivery (following preterm labor or pPROM) before 32 weeks gestation |
| Secondary | Number of Participants With Spontaneous Preterm Delivery < 35 Weeks Gestation | randomization to 35 weeks gestation (a period of up to 19 weeks) | Spontaneous preterm delivery (following preterm labor or pPROM) before 35 weeks gestation |
| Secondary | Number of Participants With Indicated Preterm Delivery for < 35 Weeks | randomization to 35 weeks gestation (a period of up to 19 weeks) | Preterm delivery prior to 35 weeks gestation with medical indications |
| Secondary | Number of Participants With Cesarean Delivery | Randomization to delivery (a period of up to 26 weeks) | Delivery by cesarean |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation | From randomization to 35 weeks gestation (a period of up to 19 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Days From Randomization to Delivery (or Fetal Demise) | Randomization to delivery (a period of up to 26 weeks) | days | MEDIAN | |
| SECONDARY | Gestational Age at Delivery or Fetal Death | Randomization to delivery (a period of up to 26 weeks) | weeks | MEDIAN | |
| SECONDARY | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation | From randomization to up to 28 weeks gestation (a period if up to 12 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation | From randomization to 32 weeks gestation (a period of up to 16 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation | randomization to 37 weeks gestation (a period of up to 21 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Spontaneous Preterm Delivery < 32 Weeks Gestation | randomization to 32 weeks gestation (a period of up to 16 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Spontaneous Preterm Delivery < 35 Weeks Gestation | randomization to 35 weeks gestation (a period of up to 19 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Indicated Preterm Delivery for < 35 Weeks | randomization to 35 weeks gestation (a period of up to 19 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Cesarean Delivery | Randomization to delivery (a period of up to 26 weeks) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation | Progesterone | 84 | Participants | ||
| Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation | Arabin Pessary | 84 | Participants | ||
| Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation | Placebo | 86 | Participants | ||
| Days From Randomization to Delivery (or Fetal Demise) | Progesterone | 86 | Inter-Quartile Range 53 to 106 | days | |
| Days From Randomization to Delivery (or Fetal Demise) | Arabin Pessary | 86 | Inter-Quartile Range 53 to 106 | days | |
| Days From Randomization to Delivery (or Fetal Demise) | Placebo | 77 | Inter-Quartile Range 51 to 101 | days | |
| Gestational Age at Delivery or Fetal Death | Progesterone | 34.1 | Inter-Quartile Range 29.0 to 36.1 | weeks | |
| Gestational Age at Delivery or Fetal Death | Arabin Pessary | 33.9 | Inter-Quartile Range 28.9 to 36.6 | weeks | |
| Gestational Age at Delivery or Fetal Death | Placebo | 33.1 | Inter-Quartile Range 27.9 to 36.2 | weeks | |
| Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation | Progesterone | 33 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Progesterone | 147 | |
| Overall Study | STARTED | Arabin Pessary | 153 | |
| Overall Study | STARTED | Placebo | 137 | |
| Overall Study | STARTED | Progesterone - Fetus/Neonates/Infants | 294 | |
| Overall Study | STARTED | Arabin Pessary - Fetus/Neonates/Infants | 306 | |
| Overall Study | STARTED | Placebo - Fetus/Neonates/Infants | 274 | |
| Overall Study | COMPLETED | Progesterone | 146 | |
| Overall Study | COMPLETED | Arabin Pessary | 152 | |
| Overall Study | COMPLETED | Placebo | 136 | |
| Overall Study | COMPLETED | Progesterone - Fetus/Neonates/Infants | 292 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events216
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vaginal soreness/discomfort | Reproductive system and breast disorders | Progesterone | 30 | 146 | 30 |
| other | Vaginal soreness/discomfort | Reproductive system and breast disorders | Arabin Pessary | 57 | 152 | 57 |
| other | Vaginal soreness/discomfort | Reproductive system and breast disorders | Placebo | 32 | 136 | 32 |
| other | Vaginal soreness/discomfort | Reproductive system and breast disorders | Progesterone - Infants | 0 | 0 | 0 |
| other | Vaginal soreness/discomfort | Reproductive system and breast disorders | Arabin Pessary - Infants | 0 | 0 | 0 |
| other | Vaginal soreness/discomfort | Reproductive system and breast disorders | Placebo - Infants | 0 | 0 | 0 |
| other | Vaginal discharge | Infections and infestations | Progesterone | 107 | 146 | 107 |
| other | Vaginal discharge | Infections and infestations | Arabin Pessary | 114 | 152 | 114 |
| other | Vaginal discharge | Infections and infestations | Placebo | 97 | 136 | 97 |
| other | Vaginal discharge | Infections and infestations | Progesterone - Infants | 0 | 0 | 0 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Progesterone | 0 | 147 |
| Total, all-cause mortality | Arabin Pessary | 0 | 153 |
| Total, all-cause mortality | Placebo | 0 | 137 |
| Total, all-cause mortality | Progesterone - Infants | 30 | 294 |
| Total, all-cause mortality | Arabin Pessary - Infants | 32 | 306 |
| Total, all-cause mortality | Placebo - Infants | 40 | 274 |
| Total, other adverse events | Progesterone | 125 | 146 |
| Total, other adverse events | Arabin Pessary | 129 | 152 |
| Total, other adverse events | Placebo | 113 | 136 |
| Total, other adverse events | Progesterone - Infants | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants20
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24HD036801 | NICHD Maternal-Fetal Medicine Units (MFMU) Network: Data CoordinatingCenter | CLIFTON, REBECCA GERSNOVIEZ | GEORGE WASHINGTON UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2021 to 2025 | NIH RePORTER |
| UG1HD027869 | Maternal-Fetal Medicine Units (MFMU) Network | TITA, ALAN THEVENET N. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD027915 | NICHD maternal fetal medicine units network | COSTANTINE, MAGED | OHIO STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD034208 | UofU Maternal-Fetal Medicine Units (MFMU) Network: Clinical Centers | METZ, TORRI D | UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040485 | Columbia University Maternal-Fetal Medicine Units Network Clinical Center | ZORK, NOELIA MILENA MODAD | COLUMBIA UNIVERSITY HEALTH SCIENCES | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040500 | Brown University/Women & Infants Hospital of Rhode Island (WIH) Center Application for the Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network | ROUSE, DWIGHT J | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040512 | Maternal Fetal Medicine Units Network - Northwestern Study Center | YEE, LYNN M | NORTHWESTERN UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040544 | Case Western Reserve University Center of the NICHD MFMU Network | GIBSON, KELLY S; RANZINI, ANGELA C. | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040545 | Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network (UG1) | MENDEZ-FIGUEROA, HECTOR | UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
| UG1HD040560 | UNC MFMU: Advancing Perinatal Health via Definitive, Multi-Site Clinical Studies | THORP, JOHN M | UNIV OF NORTH CAROLINA CHAPEL HILL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2016 to 2025 | NIH RePORTER |
1 to 10 of 20
See all 20 grantsTrial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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