Pregnancy Clinical Trial
Official title:
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
The purpose of this study is to evaluate the fetal safety of topical application of Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.
Hemorrhoids are a frequent condition in pregnancy. The rate is increased as pregnancy
progresses, and they affect up to 24% of pregnant women in the third trimester.
Complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with
perianal irritation and itching, and in severe cases, severe pain and venous engorgement
which could even lead to thrombosis and infarction. Hemorrhoids are treated with a variety
of suppositories and gels, based on analgesic and anti-inflammatory effects. The safety of
these antihemorrhoidal products has not yet been documented in pregnant women.
Proctofoam-HC® has been on the Canadian market for 25 years. It combines the
anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine
HCl. It is approved for temporary relief of anorectal inflammation, pruritus, pain and
swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and
postoperative pain.
We hypothesize that local application of Proctofoam-HC® in the third trimester of pregnancy
is safe for the mother and fetus.
;
Observational Model: Case Control, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Active, not recruiting |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Completed |
NCT02523755 -
Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia
|
Phase 4 |