Trial · NCT03360539
Nurse-Family Partnership Impact Evaluation in South Carolina
NCT03360539, Not applicable, Active not recruiting, Harvard School of Public Health (HSPH); results first posted 2025-12-12
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Nurse-Family Partnership Impact Evaluation in South Carolina. Trials, record NCT03360539. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03360539
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nurse-Family Partnership Impact Evaluation in South Carolina
- NCT number
- NCT03360539
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 5,670 participants, actual
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Conditions
- Preterm Birth, Injuries, Maternal Behavior
- Interventions
- Nurse-Family Partnership
- First posted
- 2017-12-04
- Last updated
- 2025-12-12
- Results first posted
- 2025-12-12
- Limitations and caveats
The study ended enrollment earlier than planned on March 17, 2020, due to safety concerns arising from the Coronavirus disease 2019 (COVID-19) pandemic. The original plan was to enroll 6,000 mothers (4,000 in the treatment group and 2,000 in the control group) over a four-year period (April 2016-2020), with NFP services provided through the children's second birthday (2016-2022). At the close of enrollment, a total of 5,670 participants had been enrolled.
Source ClinicalTrials.gov
Registered outcomes60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Composite Birth Outcome | 0-7 days after index birth; vital records, mortality records, and fetal death records | Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life). |
| Primary | Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | within 24 months after index birth; Medicaid claims or hospital discharge data | Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren). |
| Primary | Number of Participants With an Inter-birth Interval of < 21 Months | within 21 months after index birth; vital records | Having a subsequent birth within the first 21 months of the index birth |
| Secondary | Number of Participants With an Infant Born Small for Gestational Age (SGA) | At index birth; vital records | Infant birth weight below the 10th percentile for infants of the same gestational age |
| Secondary | Number of Participants With an Infant Born Large for Gestational Age (LGA) | At index birth birth; vital records | Infant birth weight above the 90th percentile for infants of the same gestational age |
| Secondary | Number of Participants With an Infant Born With Low Birth Weight (LBW) | At index birth; vital records | Number of participants with an infant born with a birth weight of less than 2500 grams. |
| Secondary | Number of Participants With an Infant With Very Low Birth Weight | At index birth; vital records | Number of participants with an infant born with a birth weight of less than 1500 grams. |
| Secondary | Birth Weight (Continuous) | At index birth; vital records | A continuous measure of infant birth weight (grams) |
| Secondary | Number of Participants With a Preterm Birth | At index birth; vital records | Infant born before 37 weeks' gestation (obstetric estimate) |
| Secondary | Number of Participants With an Extremely Preterm Birth | At index birth; vital records | Number of participants with an infant born before 28 weeks' gestation. |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 registered outcomesOutcomes60
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 a Composite Birth Outcome | 0-7 days after index birth; vital records, mortality records, and fetal death records | Differs from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | within 24 months after index birth; Medicaid claims or hospital discharge data | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With an Inter-birth Interval of < 21 Months | within 21 months after index birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Infant Born Small for Gestational Age (SGA) | At index birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Infant Born Large for Gestational Age (LGA) | At index birth birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Infant Born With Low Birth Weight (LBW) | At index birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Infant With Very Low Birth Weight | At index birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Birth Weight (Continuous) | At index birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | grams | MEAN |
| SECONDARY | Number of Participants With a Preterm Birth | At index birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Extremely Preterm Birth | At index birth; vital records | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 outcomesResults by group116
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 a Composite Birth Outcome | Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | 892 | Participants | ||
| Number of Participants With a Composite Birth Outcome | Control | 430 | Participants | ||
| Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | 901 | Participants | ||
| Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | Control | 438 | Participants | ||
| Number of Participants With an Inter-birth Interval of < 21 Months | Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | 363 | Participants | ||
| Number of Participants With an Inter-birth Interval of < 21 Months | Control | 199 | Participants | ||
| Number of Participants With an Infant Born Small for Gestational Age (SGA) | Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | 553 | Participants | ||
| Number of Participants With an Infant Born Small for Gestational Age (SGA) | Control | 265 | Participants | ||
| Number of Participants With an Infant Born Large for Gestational Age (LGA) | Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership | 166 | Participants | ||
| Number of Participants With an Infant Born Large for Gestational Age (LGA) | Control | 95 | Participants |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment - Participation in Nurse Family Partnership | 3,806 | |
| Overall Study | STARTED | Control | 1,864 | |
| Overall Study | Participants matched to index birth or index fetal death | Treatment - Participation in Nurse Family Partnership | 3,319 | |
| Overall Study | Participants matched to index birth or index fetal death | Control | 1,647 | |
| Overall Study | COMPLETED | Treatment - Participation in Nurse Family Partnership | 3,295 | |
| Overall Study | COMPLETED | Control | 1,637 | |
| Overall Study | NOT COMPLETED | Treatment - Participation in Nurse Family Partnership | 511 | |
| Overall Study | NOT COMPLETED | Control | 227 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment - Participation in Nurse Family Partnership | 5 | 3,319 |
| Total, all-cause mortality | Control | 2 | 1,647 |
| Total, other adverse events | Treatment - Participation in Nurse Family Partnership | 0 | 3,319 |
| Total, other adverse events | Control | 0 | 1,647 |
| Total, serious adverse events | Treatment - Participation in Nurse Family Partnership | 0 | 3,319 |
| Total, serious adverse events | Control | 0 | 1,647 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons51
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants With a Postpartum Visit | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership vs Control: Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks) | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants Whose Child Had an Emergency Department Visit | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants With a Composite Birth Outcome | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants Experiencing Perinatal Mortality | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants With a Family Planning Visit (1 Year) | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants With a Mental Health Diagnosis or Outpatient Treatment | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants With an Inter-birth Interval of < 15 Months | Trial comparisons |
| Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership vs Control: Number of Participants With Recommended Number of Well-child Visits | Trial comparisons |
1 to 10 of 51
See all 51 trial comparisonsTests0
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
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/NCT03360539
GET https://conductscience.org/api/trials/v1/NCT03360539/registered?page=2