Trial · NCT00405288
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
NCT00405288, Completed, The Hospital for Sick Children; results first posted 2014-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Safety of Proctofoam-HC in the Third Trimester of Pregnancy. Trials, record NCT00405288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00405288
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
- NCT number
- NCT00405288
- Status
- Completed
- Enrollment
- 408 participants, actual
- Lead sponsor
- The Hospital for Sick Children
- Conditions
- Hemorrhoids, Pregnancy
- Interventions
- Proctofoam-HC®
- First posted
- 2006-11-30
- Last updated
- 2014-02-05
- Results first posted
- 2014-02-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Birth-weight | until delivery | Weight of the baby measured in grams at time of birth. |
| Secondary | Gestational Age at Delivery | until delivery | Fetal gestational age at delivery |
| Secondary | Mode of Delivery | at birth | Method of delivery for both groups: vaginal or caesarean section |
| Secondary | Prematurity | at birth | birth at \<37 gestational weeks |
| Secondary | Fetal Distress | at birth | Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid |
| Secondary | Low Birth Weight at Birth | at birth | Low birth weight (birth weights \<2500 grams) |
| Secondary | Neonatal Health | at birth | Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth |
Source ClinicalTrials.gov
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Birth-weight | until delivery | Estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight at a power of 80% and alpha of 5%. Seven pairs of twin pregnancies were excluded from the comparison of birth weight. | grams | MEAN |
| SECONDARY | Gestational Age at Delivery | until delivery | gestational weeks | MEAN | |
| SECONDARY | Mode of Delivery | at birth | participants | NUMBER | |
| SECONDARY | Prematurity | at birth | participants | NUMBER | |
| SECONDARY | Fetal Distress | at birth | participants | NUMBER | |
| SECONDARY | Low Birth Weight at Birth | at birth | Per protocol, the estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight (primary outcome) for a power of 80% and alpha of 5% was used. | participants | NUMBER |
| SECONDARY | Neonatal Health | at birth | participants | NUMBER | |
| POST_HOC | Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth | neonatal period | participants | NUMBER | |
| POST_HOC | Respiratory Neonatal Health Concerns | neonatal period | participants | NUMBER | |
| POST_HOC | Neonatal Health Concerns-infections | neonatal period | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Birth-weight | Proctofoam-HC® | 3406.9 | Standard Deviation 452.7 | grams | |
| Birth-weight | Control | 3487.7 | Standard Deviation 491.4 | grams | |
| Gestational Age at Delivery | Proctofoam-HC® | 39.4 | Standard Deviation 1.4 | gestational weeks | |
| Gestational Age at Delivery | Control | 39.1 | Standard Deviation 2.5 | gestational weeks | |
| Mode of Delivery | Proctofoam-HC® | Vaginal delivery | 173 | participants | |
| Mode of Delivery | Control | Vaginal delivery | 146 | participants | |
| Mode of Delivery | Proctofoam-HC® | Caesarean section | 31 | participants | |
| Mode of Delivery | Control | Caesarean section | 55 | participants | |
| Mode of Delivery | Proctofoam-HC® | Unknown | 0 | participants | |
| Mode of Delivery | Control | Unknown | 3 | participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Proctofoam-HC® | 204 | |
| Overall Study | STARTED | Control | 204 | |
| Overall Study | COMPLETED | Proctofoam-HC® | 204 | |
| Overall Study | COMPLETED | Control | 204 | |
| Overall Study | NOT COMPLETED | Proctofoam-HC® | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
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 | Proctofoam-HC® | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Proctofoam-HC® | 0 | 204 |
| Total, other adverse events | Control | 0 | 204 |
| Total, serious adverse events | Proctofoam-HC® | 0 | 204 |
| Total, serious adverse events | Control | 0 | 204 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Proctofoam-HC® vs Control: serious adverse events |
Source Trial comparisons
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
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/NCT00405288
GET https://conductscience.org/api/trials/v1/NCT00405288/results?page=2