Trial · NCT01559012

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

NCT01559012, Phase 3, Completed, A.O.U. Città della Salute e della Scienza; results first posted 2014-04-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum. Trials, record NCT01559012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01559012

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Trial

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

Title: Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
NCT number: NCT01559012
Status: Completed
Phases: Phase 3
Enrollment: 13 participants, actual
Lead sponsor: A.O.U. Città della Salute e della Scienza
Conditions: Hyperemesis Gravidarum
Interventions: Clonidine
First posted: 2012-03-20
Last updated: 2014-04-30
Results first posted: 2014-04-30
Limitations and caveats: Efficacy and safety issues are represented by maternal exposure in a critical period for organogenesis and hypotensive effect of the drug.~Findings based on a very limited number of women limit the reliability of results

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	PUQE Score for Assessment of Severity in Hyperemesis Gravidarum	Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.	PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy. It is composed of three items; every item has a score from 1 (best) to 5 (worst). The sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.
Primary	VAS Score for Assessment of Severity in Hyperemesis Gravidarum	Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.	VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.
Secondary	Morning Urine Ketonuria	participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days	Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting
Secondary	Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.	participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days	The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis. All patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms.
Secondary	Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only	participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days	if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.
Secondary	Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.	at 10 days since start of treatment	the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective
Secondary	Pregnancy Outcome Measures: Birth Weight.	at delivery	Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.
Secondary	Newborn Outcome Measure: APGAR Score.	at 1 minute and at 5 minutes after delivery	The APGAR score is the most common indicator of neonatal status immediately after delivery. The test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's: Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.
Secondary	Systolic Blood Pressure	10 days	Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)
Secondary	Diastolic Blood Pressure	10 days	Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	PUQE Score for Assessment of Severity in Hyperemesis Gravidarum	Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.	A sample size calculation for crossover studies using a model available on line (MGH Mallinckrodt General Clinical Research Center - Harvard Medical School) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01 and a beta \> 0.90.	units on a scale	MEAN
PRIMARY	VAS Score for Assessment of Severity in Hyperemesis Gravidarum	Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.		units on a scale	MEAN
SECONDARY	Morning Urine Ketonuria	participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days		Proportion of person-days	MEAN
SECONDARY	Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.	participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days		daily doses of antiemetics	MEAN
SECONDARY	Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only	participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days		Proportion of person-days	MEAN
SECONDARY	Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.	at 10 days since start of treatment	no determination of sample size	participants	NUMBER
SECONDARY	Pregnancy Outcome Measures: Birth Weight.	at delivery	no determination of sample size Recording for safety issue	grams	MEAN
SECONDARY	Newborn Outcome Measure: APGAR Score.	at 1 minute and at 5 minutes after delivery	APGAR score of newborns at 1 minute and at 5 minutes	units on a scale	MEAN
SECONDARY	Systolic Blood Pressure	10 days		mmHg	MEAN
SECONDARY	Diastolic Blood Pressure	10 days		mmHg	MEAN

Source ClinicalTrials.gov

Results by group19

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

Outcome	Group	Value	Spread	Units
PUQE Score for Assessment of Severity in Hyperemesis Gravidarum	Clonidine	6.3	95% Confidence Interval 5.5-7.11	units on a scale
PUQE Score for Assessment of Severity in Hyperemesis Gravidarum	Placebo	8.5	95% Confidence Interval 7.3-9.3	units on a scale
VAS Score for Assessment of Severity in Hyperemesis Gravidarum	Clonidine	22	95% Confidence Interval 19 to 26	units on a scale
VAS Score for Assessment of Severity in Hyperemesis Gravidarum	Placebo	29	95% Confidence Interval 2.58	units on a scale
Morning Urine Ketonuria	Clonidine	0.06	95% Confidence Interval 0.04 to 0.18	Proportion of person-days
Morning Urine Ketonuria	Placebo	0.36	95% Confidence Interval 0.24 to 0.47	Proportion of person-days
Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.	Clonidine	1.5	95% Confidence Interval 1.1 to 2.9	daily doses of antiemetics
Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.	Placebo	2.3	95% Confidence Interval 1.9 to 3.0	daily doses of antiemetics
Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only	Clonidine	0.40	95% Confidence Interval 0.28 to 0.54	Proportion of person-days
Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only	Placebo	0.20	95% Confidence Interval 0.09 to 0.36	Proportion of person-days

1 to 10 of 19Source ClinicalTrials.gov

See all 19 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Clonidine First - Placebo Second	6
Overall Study	STARTED	Placebo First - Clonidine Second	7
Overall Study	COMPLETED	Clonidine First - Placebo Second	6
Overall Study	COMPLETED	Placebo First - Clonidine Second	6
Overall Study	NOT COMPLETED	Clonidine First - Placebo Second	0
Overall Study	NOT COMPLETED	Placebo First - Clonidine Second	1

Source ClinicalTrials.gov

Adverse events2

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	Itching	Skin and subcutaneous tissue disorders	Clonidine	0	6	0
other	Itching	Skin and subcutaneous tissue disorders	Placebo	1	7	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Clonidine
Total, all-cause mortality	Placebo
Total, other adverse events	Clonidine	0	6
Total, other adverse events	Placebo	1	7
Total, serious adverse events	Clonidine	0	6
Total, serious adverse events	Placebo	0	7

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24684734	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Clonidine vs Placebo: Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.	Trial comparisons
Clonidine vs Placebo: serious adverse events	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.

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/NCT01559012

GET https://conductscience.org/api/trials/v1/NCT01559012/registered

API reference For AI assistants