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Condition (MeSH)

Premature Birth

ClinicalTrials.gov lists 2,516 trials for Premature Birth or a narrower condition beneath it. NICHD Neonatal Research Network has the most among industry and government lead sponsors, with 41.

MeSH D047928 Urogenital Diseases C12
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Phase 1 Phase 1 69 Phase 1/2 Phase 1/2 30 Phase 2 Phase 2 88 Phase 2/3 Phase 2/3 44 Phase 3 Phase 3 136 Phase 4 Phase 4 117 Not applicable Not applicable 1,216 Observational Observational 814 Phase 1 Phase 1 69 Phase 1/2 Phase 1/2 30 Phase 2 Phase 2 88 Phase 2/3 Phase 2/3 44 Phase 3 Phase 3 136 Phase 4 Phase 4 117 Not applicable Not applicable 1,216 Observational Observational 814

Trials per phase (log scale)

1 more section with rows

2,516 of the 2,516 trials are tagged with Premature Birth itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Premature Birth trials start? (37)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 4 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 172

1990: 2 trials (Observational 1, Not applicable 1) 1991: 1 trials (Phase 2/3 1) 1992: 2 trials (Not applicable 1, Phase 3 1) 1993: 5 trials (Observational 3, Phase 3 2) 1994: 3 trials (Observational 2, Phase 2/3 1) 1995: 1 trials (Observational 1) 1996: 6 trials (Observational 1, Not applicable 2, Phase 3 1, Phase 1/2 1, Phase 1 1) 1997: 6 trials (Observational 3, Phase 4 1, Phase 3 1, Phase 2/3 1) 1998: 5 trials (Observational 3, Not applicable 1, Phase 3 1) 1999: 5 trials (Observational 2, Not applicable 1, Phase 3 1, Phase 2 1) 2000: 7 trials (Observational 1, Not applicable 3, Phase 3 1, Phase 1/2 2) 2001: 11 trials (Observational 1, Not applicable 4, Phase 4 2, Phase 3 3, Phase 2/3 1) 2002: 17 trials (Observational 4, Not applicable 4, Phase 4 3, Phase 3 3, Phase 1/2 2, Phase 1 1) 2003: 23 trials (Observational 4, Not applicable 8, Phase 4 2, Phase 3 6, Phase 2/3 1, Phase 2 2) 2004: 28 trials (Observational 5, Not applicable 11, Phase 4 3, Phase 3 4, Phase 2/3 1, Phase 2 4) 2005: 48 trials (Observational 11, Not applicable 12, Phase 4 3, Phase 3 8, Phase 2/3 1, Phase 2 8, Phase 1/2 2, Phase 1 3) 2006: 61 trials (Observational 14, Not applicable 23, Phase 4 5, Phase 3 9, Phase 2 7, Phase 1 3) 2007: 52 trials (Observational 19, Not applicable 17, Phase 4 7, Phase 3 4, Phase 2 2, Phase 1/2 1, Phase 1 2) 2008: 64 trials (Observational 28, Not applicable 18, Phase 4 2, Phase 3 8, Phase 2/3 3, Phase 2 3, Phase 1 2) 2009: 54 trials (Observational 23, Not applicable 19, Phase 4 4, Phase 3 1, Phase 2/3 3, Phase 1/2 1, Phase 1 3) 2010: 65 trials (Observational 22, Not applicable 23, Phase 4 5, Phase 3 6, Phase 2 5, Phase 1/2 2, Phase 1 2) 2011: 98 trials (Observational 33, Not applicable 39, Phase 4 6, Phase 3 9, Phase 2/3 1, Phase 2 3, Phase 1/2 1, Phase 1 6) 2012: 72 trials (Observational 22, Not applicable 29, Phase 4 5, Phase 3 4, Phase 2/3 1, Phase 2 7, Phase 1 4) 2013: 103 trials (Observational 38, Not applicable 43, Phase 4 4, Phase 3 5, Phase 2/3 2, Phase 2 4, Phase 1/2 2, Phase 1 5) 2014: 104 trials (Observational 37, Not applicable 47, Phase 4 4, Phase 3 3, Phase 2/3 3, Phase 2 7, Phase 1/2 1, Phase 1 2) 2015: 110 trials (Observational 37, Not applicable 51, Phase 4 5, Phase 3 7, Phase 2/3 2, Phase 2 3, Phase 1/2 1, Phase 1 4) 2016: 114 trials (Observational 37, Not applicable 56, Phase 4 5, Phase 3 10, Phase 2/3 2, Phase 2 1, Phase 1 3) 2017: 122 trials (Observational 38, Not applicable 66, Phase 4 7, Phase 3 5, Phase 2/3 4, Phase 1/2 1, Phase 1 1) 2018: 172 trials (Observational 57, Not applicable 95, Phase 4 6, Phase 3 4, Phase 2/3 1, Phase 2 4, Phase 1/2 2, Phase 1 3) 2019: 154 trials (Observational 53, Not applicable 80, Phase 4 5, Phase 3 6, Phase 2/3 1, Phase 2 3, Phase 1/2 2, Phase 1 4) 2020: 142 trials (Observational 52, Not applicable 78, Phase 4 4, Phase 3 1, Phase 2/3 2, Phase 2 2, Phase 1 3) 2021: 154 trials (Observational 53, Not applicable 84, Phase 4 6, Phase 3 5, Phase 2/3 1, Phase 2 3, Phase 1 2) 2022: 152 trials (Observational 49, Not applicable 88, Phase 4 3, Phase 3 2, Phase 2/3 1, Phase 2 4, Phase 1/2 1, Phase 1 4) 2023: 143 trials (Observational 41, Not applicable 83, Phase 4 7, Phase 2/3 4, Phase 2 4, Phase 1/2 1, Phase 1 3) 2024: 141 trials (Observational 36, Not applicable 89, Phase 4 4, Phase 3 5, Phase 2/3 2, Phase 2 2, Phase 1/2 1, Phase 1 2) 2025: 136 trials (Observational 48, Not applicable 71, Phase 4 6, Phase 3 3, Phase 2/3 1, Phase 2 3, Phase 1/2 1, Phase 1 3)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 118
2025 136
2024 141
2023 143
2022 152
2021 154
2020 142
2019 154
2018 172
2017 122

Forecast of the full-year count, planned starts included, not rows of this table: about 130 trials starting in 2026 and about 140 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 170 trials still running at the 2026-10-09 snapshot; registered median of 24 months across 1,561 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Premature Birth trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 69
Phase 1/2 30
Phase 2 88
Phase 2/3 44
Phase 3 136
Phase 4 117
Not applicable 1,216
Observational 814
Expanded access 2

How many Premature Birth trials are recruiting? (11)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 130
Recruiting 243
Enrolling by invitation 17
Active, not recruiting 82
Completed 1,375

Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Premature Birth trials? (2)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
NICHD Neonatal Research Network 41
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 16

Which drugs are being tested for Premature Birth? (1)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Retosiban 9

Interventions as named in the registry (14)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Progesterone 8% 23
Standard Care 16
Vaginal Progesterone 15
Control (placebo) group 15
citrate of caffeine 14

These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Premature Birth trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Stillbirth/neonatal death 5,079 1
Patent Ductus Aretriosus 631 1
Congenital anomaly 596 2
Death 487 18
Neonatal death up to 28 days 353 1

Which publications cover Premature Birth? (1,458)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.

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