Page last updated: 2024-10-25

clonidine and Pernicious Vomiting of Pregnancy

clonidine has been researched along with Pernicious Vomiting of Pregnancy in 2 studies

Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.
clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.

Research Excerpts

ExcerptRelevanceReference
"To study the efficacy of transdermal clonidine in the treatment of severe refractory hyperemesis gravidarum (HG), the most severe illness of pregnancy."5.19Transdermal clonidine in the treatment of severe hyperemesis. A pilot randomised control trial: CLONEMESI. ( Arrotta, M; Cicogna, L; Donvito, V; Maina, A; Mischinelli, M; Rivolo, S; Todros, T, 2014)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's2 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Maina, A1
Arrotta, M1
Cicogna, L1
Donvito, V1
Mischinelli, M1
Todros, T1
Rivolo, S1
Stephansson, O1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The CLONEMESI Study: a Randomized Placebo-controlled Study With Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum.[NCT01559012]Phase 313 participants (Actual)Interventional2012-02-29Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.

"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." (NCT01559012)
Timeframe: 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

Interventiondaily doses of antiemetics (Mean)
Clonidine1.5
Placebo2.3

Diastolic Blood Pressure

Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle (NCT01559012)
Timeframe: 10 days

InterventionmmHg (Mean)
Clonidine58
Placebo61

Morning Urine Ketonuria

Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting (NCT01559012)
Timeframe: 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

InterventionProportion of person-days (Mean)
Clonidine0.06
Placebo0.36

Newborn Outcome Measure: APGAR Score.

"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." (NCT01559012)
Timeframe: at 1 minute and at 5 minutes after delivery

Interventionunits on a scale (Mean)
APGAR Score at 1'9
APGAR Score at 5'9

Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only

if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy. (NCT01559012)
Timeframe: 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

InterventionProportion of person-days (Mean)
Clonidine0.40
Placebo0.20

Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.

the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective (NCT01559012)
Timeframe: at 10 days since start of treatment

Interventionparticipants (Number)
Clonidine9
Placebo3

Pregnancy Outcome Measures: Birth Weight.

Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG. (NCT01559012)
Timeframe: at delivery

Interventiongrams (Mean)
Mean Birth Weight of 12 Patients3312

PUQE Score for Assessment of Severity in Hyperemesis Gravidarum

"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." (NCT01559012)
Timeframe: 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.

Interventionunits on a scale (Mean)
Clonidine6.3
Placebo8.5

Systolic Blood Pressure

Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days) (NCT01559012)
Timeframe: 10 days

InterventionmmHg (Mean)
Clonidine91
Placebo97

VAS Score for Assessment of Severity in Hyperemesis Gravidarum

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. (NCT01559012)
Timeframe: 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.

Interventionunits on a scale (Mean)
Clonidine22
Placebo29

Trials

1 trial available for clonidine and Pernicious Vomiting of Pregnancy

ArticleYear
Transdermal clonidine in the treatment of severe hyperemesis. A pilot randomised control trial: CLONEMESI.
    BJOG : an international journal of obstetrics and gynaecology, 2014, Volume: 121, Issue:12

    Topics: Administration, Cutaneous; Adult; Antiemetics; Clonidine; Cross-Over Studies; Double-Blind Method; D

2014

Other Studies

1 other study available for clonidine and Pernicious Vomiting of Pregnancy

ArticleYear
A novel study on transdermal clonidine treatment of hyperemesis gravidarum.
    BJOG : an international journal of obstetrics and gynaecology, 2014, Volume: 121, Issue:12

    Topics: Antiemetics; Clonidine; Female; Humans; Hyperemesis Gravidarum; Pregnancy

2014