Trial · NCT02133573

Randomized Trial of Maternal Progesterone Therapy

NCT02133573, Phase 2, Completed, Children's Hospital of Philadelphia; results first posted 2023-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Trial of Maternal Progesterone Therapy. Trials, record NCT02133573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02133573

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Trial of Maternal Progesterone Therapy
NCT number: NCT02133573
Status: Completed
Phases: Phase 2
Enrollment: 102 participants, actual
Lead sponsor: Children's Hospital of Philadelphia
Conditions: Congenital Heart Disease, Periventricular Leucomalacia, Brain Development, Cardiac Surgery, Neurodevelopmental Disability, Fetal Neuroprotection
Interventions: Progesterone, Vaginal lubricant
First posted: 2014-05-08
Last updated: 2023-08-09
Results first posted: 2023-02-28

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Motor Scale of the Bayley Scales of Infant and Toddler Development-III	When baby is 18 months of age	The composite motor score is normed and has a mean of 100 (SD 15) and a range of 40-160. Scores between 71 and 85 indicate mild impairment and scores lower than 70 indicate moderate or severe impairment.
Secondary	Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	When baby is 18 months of age	The composite cognitive and language scores are normed and have a mean of 100 (SD 15) and a range of 40-160. Scores between 71 and 85 indicate mild impairment and scores lower than 70 indicate moderate or severe impairment.
Secondary	Fetal Brain Growth and Maturation by MRI	fTMS score change from 24-28 weeks gestational age to 34-36 weeks gestational age	Total maturation scale (TMS) is an observational rating scale to assess the appropriateness of the gross brain appearance on MRI. The TMS scale has been used to demonstrate the negative effect of heart anatomy on post-natal, pre-surgical brain MRIs in infants with congenital heart. Similarly, a fetal TMS scale (fTMS) was developed to define the progress of brain development in-utero. Here we use the fTMS to define developmental/maturational changes occurring during gestation. The fTMS was graded on an ordinal scale, minimum = 4, maximum = 17 where a lower number indicates a less mature fetal brain and a higher number indicates a more mature fetal brain on MRI.
Secondary	Myelination During Fetal Brain Development by MRI	Change from 24-28 weeks gestational age to 34-36 weeks gestational age	Myelination is part of the fetal TMS rating system and is scored as follows. 1. \- If there is myelin in the brainstem, cerebellar peduncle and inferior tectum only 2. \- If there is myelin in the ventrolateral thalamus as well as in #1 3. \- If there is myelin present in the posterior limb of the internal capsule as well as in #2
Secondary	Prevalence of PVL/WMI in the Pre Operative Study Participants	Preoperative on day of surgery	Periventricular leukomalacia (PVL), also known in the literature as white matter injury (WMI), is an acquired brain injury to the white matter of the brain seen in 20% of infants with congenital heart and up to 80% post-operatively. PVL/WMI is seen on T1 MPR sequences as abnormal hyperintensities in the white matter which are quantified by manual segmentation to achieve total volumes and regional volumes of the injury. Yes indicates the presence of PVL and no indicates the absence of PVL on the pre operative MRI.
Secondary	Prevalence of PVL/WMI in the Post Operative Study Participants	Postoperative within 10 days of surgery	PVL/WMI will be measured on the post operative brain MRI with manual segmentations from the T1MPR sequence. Yes indicates the presence of new or worse PVL and no indicates the absence of new or worse PVL on the post operative MRI.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Motor Scale of the Bayley Scales of Infant and Toddler Development-III	When baby is 18 months of age	Per protocol population, all children who completed the 18 month follow up visit.	score on a scale	MEAN
SECONDARY	Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	When baby is 18 months of age	Per protocol population, all children who completed the 18 month follow up visit.	score on a scale	MEAN
SECONDARY	Fetal Brain Growth and Maturation by MRI	fTMS score change from 24-28 weeks gestational age to 34-36 weeks gestational age	Number of participants who completed both fetal MRIs and had reliable TMS scores.	score on a scale	MEAN
SECONDARY	Myelination During Fetal Brain Development by MRI	Change from 24-28 weeks gestational age to 34-36 weeks gestational age	Number of participants who completed both fetal MRIs and had reliable myelination scores.	score on a scale	MEAN
SECONDARY	Prevalence of PVL/WMI in the Pre Operative Study Participants	Preoperative on day of surgery	The number of participants who completed a pre operative MRI.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Prevalence of PVL/WMI in the Post Operative Study Participants	Postoperative within 10 days of surgery	The number of participants who completed a post operative MRI.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group25

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Motor Scale of the Bayley Scales of Infant and Toddler Development-III	Progesterone		90.0	Standard Deviation 11.5	score on a scale
Motor Scale of the Bayley Scales of Infant and Toddler Development-III	Vaginal Lubricant		87.5	Standard Deviation 12.7	score on a scale
Motor Scale of the Bayley Scales of Infant and Toddler Development-III	Overall		88.7	Standard Deviation 12.1	score on a scale
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	Progesterone	Bayley Cognitive Score (Composite)	92.4	Standard Deviation 12.2	score on a scale
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	Vaginal Lubricant	Bayley Cognitive Score (Composite)	91.2	Standard Deviation 11.4	score on a scale
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	Overall	Bayley Cognitive Score (Composite)	91.8	Standard Deviation 11.8	score on a scale
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	Progesterone	Bayley Language Score (Composite)	86.1	Standard Deviation 15.1	score on a scale
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	Vaginal Lubricant	Bayley Language Score (Composite)	84.5	Standard Deviation 18.9	score on a scale
Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III	Overall	Bayley Language Score (Composite)	85.3	Standard Deviation 16.9	score on a scale
Fetal Brain Growth and Maturation by MRI	Progesterone		8.84	Standard Deviation 1.19	score on a scale

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Progesterone	52
Overall Study	STARTED	Vaginal Lubricant	50
Overall Study	Dyads Allocated to Intervention	Progesterone	52
Overall Study	Dyads Allocated to Intervention	Vaginal Lubricant	49
Overall Study	Number of Toddlers That Returned for 18 Month Follow Up Visit	Progesterone	45
Overall Study	Number of Toddlers That Returned for 18 Month Follow Up Visit	Vaginal Lubricant	43
Overall Study	Number of Toddlers With Analyzed Primary Endpoint	Progesterone	43
Overall Study	Number of Toddlers With Analyzed Primary Endpoint	Vaginal Lubricant	42
Overall Study	COMPLETED	Progesterone	43
Overall Study	COMPLETED	Vaginal Lubricant	42

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events596

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 Discharge	Reproductive system and breast disorders	Progesterone (Maternal Adverse Events)	33	52	43
other	Vaginal Discharge	Reproductive system and breast disorders	Vaginal Lubricant (Maternal Adverse Events)	32	50	38
other	Vaginal Discharge	Reproductive system and breast disorders	Progesterone (Child Adverse Events)	0	0	0
other	Vaginal Discharge	Reproductive system and breast disorders	Vaginal Lubricant (Child Adverse Events)	0	0	0
other	Uterine Pain	Reproductive system and breast disorders	Progesterone (Maternal Adverse Events)	11	52	14
other	Uterine Pain	Reproductive system and breast disorders	Vaginal Lubricant (Maternal Adverse Events)	12	50	13
other	Uterine Pain	Reproductive system and breast disorders	Progesterone (Child Adverse Events)	0	0	0
other	Uterine Pain	Reproductive system and breast disorders	Vaginal Lubricant (Child Adverse Events)	0	0	0
other	Vaginal Pain	Reproductive system and breast disorders	Progesterone (Maternal Adverse Events)	12	52	12
other	Vaginal Pain	Reproductive system and breast disorders	Vaginal Lubricant (Maternal Adverse Events)	14	50	15

1 to 10 of 596Source ClinicalTrials.gov

See all 596 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Progesterone (Maternal Adverse Events)	0	52
Total, all-cause mortality	Vaginal Lubricant (Maternal Adverse Events)	0	50
Total, all-cause mortality	Progesterone (Child Adverse Events)	3	50
Total, all-cause mortality	Vaginal Lubricant (Child Adverse Events)	5	49
Total, other adverse events	Progesterone (Maternal Adverse Events)	51	52
Total, other adverse events	Vaginal Lubricant (Maternal Adverse Events)	48	50
Total, other adverse events	Progesterone (Child Adverse Events)	48	50
Total, other adverse events	Vaginal Lubricant (Child Adverse Events)	48	49
Total, serious adverse events	Progesterone (Maternal Adverse Events)	0	52
Total, serious adverse events	Vaginal Lubricant (Maternal Adverse Events)	1	50

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38805228	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02133573

GET https://conductscience.org/api/trials/v1/NCT02133573/results?page=2

API reference For AI assistants