doxylamine and Pernicious Vomiting of Pregnancy studies

Doxylamine: Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in PARKINSONISM.

Research Excerpts

Excerpt	Relevance	Reference
"Our investigation showed ondansetron to be superior to the combination of pyridoxine and doxylamine in the treatment of nausea and emesis in pregnancy."	9.19	Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. ( Capp, SM; Carstairs, SD; Oliveira, LG; Riffenburgh, RH; You, WB, 2014)
"Our investigation showed ondansetron to be superior to the combination of pyridoxine and doxylamine in the treatment of nausea and emesis in pregnancy."	5.19	Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. ( Capp, SM; Carstairs, SD; Oliveira, LG; Riffenburgh, RH; You, WB, 2014)
"For mild symptoms of nausea and emesis of pregnancy, ginger, pyridoxine, antihistamines, and metoclopramide were associated with greater benefit than placebo."	4.93	Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy: A Systematic Review. ( Beyer, F; Bradley, J; Bryant, A; McParlin, C; Moloney, E; Muirhead, CR; Nelson-Piercy, C; Newbury-Birch, D; Norman, J; O'Donnell, A; Robson, SC; Shaw, C; Simpson, E; Swallow, B; Vale, L; Yates, L, 2016)
"Of note, co-existing gastroesophageal reflux disease (GERD), Helicobacter pylori infection, and psychosocial factors may have a negative impact on the management of NVP."	2.50	The outpatient management and special considerations of nausea and vomiting in pregnancy. ( Clark, SM; Dutta, E; Hankins, GD, 2014)

Research

Studies (17)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Level of Nausea After Eversion of the Uterus

Timeframe	Studies, this research(%)	All Research%
pre-1990	4 (23.53)	18.7374
1990's	2 (11.76)	18.2507
2000's	4 (23.53)	29.6817
2010's	7 (41.18)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Fejzo, MS	1
Trovik, J	1
Grooten, IJ	1
Sridharan, K	1
Roseboom, TJ	1
Vikanes, Å	1
Painter, RC	1
Mullin, PM	1
Oliveira, LG	1
Capp, SM	1
You, WB	1
Riffenburgh, RH	1
Carstairs, SD	1
Clark, SM	1
Dutta, E	1
Hankins, GD	1
McParlin, C	1
O'Donnell, A	1
Robson, SC	1
Beyer, F	1
Moloney, E	1
Bryant, A	1
Bradley, J	1
Muirhead, CR	1
Nelson-Piercy, C	1
Newbury-Birch, D	1
Norman, J	1
Shaw, C	1
Simpson, E	1
Swallow, B	1
Yates, L	1
Vale, L	1
Pimlott, N	1
Kvern, B	1
Woollard, R	1
Niebyl, JR	1
Tan, PC	1
Omar, SZ	1
Quinla, JD	1
Hill, DA	1
Koren, G	1
Maltepe, C	1
Thukral, C	1
Wolf, JL	1
Mitchell, AA	1
Schwingl, PJ	1
Rosenberg, L	1
Louik, C	1
Shapiro, S	1
Linehan, SJ	1
Strong, TH	1
Check, WA	1
Milkovich, L	1
van den Berg, BJ	1
Munro, CD	1
Zierler, S	1
Rothman, KJ	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022[NCT06055192]		200 participants (Anticipated)	Observational	2023-09-30	Not yet recruiting
Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy[NCT01668069]		36 participants (Actual)	Interventional	2012-10-31	Completed
The Effect of Adjuvant Hypnosis Added to Conventional Therapy on Nausea and Vomiting in Hyperemesis Gravidarum: A Prospective Randomized Study[NCT04828967]		41 participants (Actual)	Interventional	2017-01-01	Completed
Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?[NCT02960113]	Phase 4	240 participants (Actual)	Interventional	2016-05-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after eversion of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: After eversion of the uterus until replacement of the uterus

Level of Nausea After Replacement of the Uterus

Intervention	units on a scale (Mean)
Scopolamine Patch	1.28
Acupressure Point P6	1.09
Scopolamine Patch + Acupressure Point P6	1.40

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after replacement of the uterus. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: After replacement of the uterus and to the next 15 minutes

Level of Nausea After the Administration of the Regional Anesthesia Medications

Intervention	units on a scale (Mean)
Scopolamine Patch	2.19
Acupressure Point P6	2.19
Scopolamine Patch + Acupressure Point P6	2.51

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after the administration of the regional anesthesia medications. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: From administration of anaesthesia until eversion of uterus

Level of Nausea Upon Arrival to the Post-operative Recovery Room

Intervention	units on a scale (Mean)
Scopolamine Patch	2.71
Acupressure Point P6	2.57
Scopolamine Patch + Acupressure Point P6	2.84

Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) upon arrival to the post-operative recovery room. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. (NCT02960113)
Timeframe: 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit

Number of Patients With Nausea

Intervention	units on a scale (Mean)
Scopolamine Patch	0.18
Acupressure Point P6	0.25
Scopolamine Patch + Acupressure Point P6	0.23

The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group. (NCT02960113)
Timeframe: Throughout the entire surgical procedure

Number of Patients With Vomiting

Intervention	Participants (Count of Participants)
Scopolamine Patch	40
Acupressure Point P6	39
Scopolamine Patch + Acupressure Point P6	46

The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: Throughout the surgical procedure

Number of Patients With Vomiting After Eversion of the Uterus

Intervention	Participants (Count of Participants)
Scopolamine Patch	24
Acupressure Point P6	25
Scopolamine Patch + Acupressure Point P6	31

Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. (NCT02960113)
Timeframe: After eversion of to replacement of the uterus

Number of Patients With Vomiting After Replacement of the Uterus

Intervention	Participants (Count of Participants)
Scopolamine Patch	8
Acupressure Point P6	6
Scopolamine Patch + Acupressure Point P6	9

Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications

Intervention	Participants (Count of Participants)
Scopolamine Patch	10
Acupressure Point P6	15
Scopolamine Patch + Acupressure Point P6	12

Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room

Intervention	Participants (Count of Participants)
Scopolamine Patch	20
Acupressure Point P6	15
Scopolamine Patch + Acupressure Point P6	20

Satisfaction With Intraoperative Antiemetic Treatment

Intervention	Participants (Count of Participants)
Scopolamine Patch	1
Acupressure Point P6	1
Scopolamine Patch + Acupressure Point P6	4

Patients are asked their nausea and vomiting treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Patients are also asked their overall satisfaction with the procedure (0 = Not Satisfied, 10 = Extremely Satisfied). (NCT02960113)
Timeframe: Throughout the surgical procedure

Article	Year
Nausea and vomiting of pregnancy and hyperemesis gravidarum. Nature reviews. Disease primers, 2019, 09-12, Volume: 5, Issue:1 Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Growth Differentiation Factor 15; H	2019
The outpatient management and special considerations of nausea and vomiting in pregnancy. Seminars in perinatology, 2014, Volume: 38, Issue:8 Topics: Ambulatory Care; Antiemetics; Diet Therapy; Doxylamine; Female; Fluid Therapy; Gastroesophageal Refl	2014
Treatments for Hyperemesis Gravidarum and Nausea and Vomiting in Pregnancy: A Systematic Review. JAMA, 2016, 10-04, Volume: 316, Issue:13 Topics: Acupuncture; Adrenal Cortex Hormones; Antiemetics; Doxylamine; Female; Histamine Antagonists; Humans	2016
Clinical practice. Nausea and vomiting in pregnancy. The New England journal of medicine, 2010, Oct-14, Volume: 363, Issue:16 Topics: Adult; Chorionic Gonadotropin; Complementary Therapies; Diagnosis, Differential; Dicyclomine; Doxyla	2010
Contemporary approaches to hyperemesis during pregnancy. Current opinion in obstetrics & gynecology, 2011, Volume: 23, Issue:2 Topics: Adrenal Cortex Hormones; Antiemetics; Diet; Doxylamine; Female; Humans; Hyperemesis Gravidarum; Obst	2011
Nausea and vomiting of pregnancy. American family physician, 2003, Jul-01, Volume: 68, Issue:1 Topics: Acupressure; Antiemetics; Diagnosis, Differential; Doxylamine; Female; Humans; Hyperemesis Gravidaru	2003
Therapy insight: drugs for gastrointestinal disorders in pregnant women. Nature clinical practice. Gastroenterology & hepatology, 2006, Volume: 3, Issue:5 Topics: Antiemetics; Constipation; Diarrhea; Doxylamine; Female; Gastroesophageal Reflux; Gastrointestinal D	2006
Alternative therapies of morning sickness. Clinical obstetrics and gynecology, 2001, Volume: 44, Issue:4 Topics: Acupressure; Antiemetics; Complementary Therapies; Dicyclomine; Doxylamine; Drug Combinations; Femal	2001

Article	Year
Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. Obstetrics and gynecology, 2014, Volume: 124, Issue:4 Topics: Adult; Antiemetics; Double-Blind Method; Doxylamine; Drug Therapy, Combination; Female; Follow-Up St	2014
Pre-emptive therapy for severe nausea and vomiting of pregnancy and hyperemesis gravidarum. Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2004, Volume: 24, Issue:5 Topics: Adult; Antiemetics; Dicyclomine; Doxylamine; Drug Administration Schedule; Drug Combinations; Female	2004
An evaluation of the teratogenicity of certain antinauseant drugs. American journal of obstetrics and gynecology, 1976, May-15, Volume: 125, Issue:2 Topics: Abnormalities, Drug-Induced; Antiemetics; Clinical Trials as Topic; Cyclizine; Dicyclomine; Doxylami	1976

Article	Year
Motherisk and Canadian Family Physician. Canadian family physician Medecin de famille canadien, 2017, Volume: 63, Issue:1 Topics: Canada; Doxylamine; Female; Guideline Adherence; Humans; Hyperemesis Gravidarum; Physicians, Family;	2017
Birth defects in relation to Bendectin use in pregnancy. II. Pyloric stenosis. American journal of obstetrics and gynecology, 1983, Dec-01, Volume: 147, Issue:7 Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Hyperemesis	1983
Drug therapies for hyperemesis gravidarum. Canadian family physician Medecin de famille canadien, 1997, Volume: 43 Topics: Administration, Oral; Antiemetics; Doxylamine; Female; Humans; Hyperemesis Gravidarum; Infusions, In	1997
CDC study: no evidence for teratogenicity of Bendectin. JAMA, 1979, Dec-07, Volume: 242, Issue:23 Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Heart	1979
Drugs in pregnancy. Australian College of Midwives Incorporated journal, 1990, Volume: 2, Issue:4 Topics: Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Hyperemesis Gravidarum; Pregnancy; Pyrid	1990
Congenital heart disease in relation to maternal use of Bendectin and other drugs in early pregnancy. The New England journal of medicine, 1985, Aug-08, Volume: 313, Issue:6 Topics: Acetaminophen; Adult; Anti-Bacterial Agents; Antiemetics; Aspirin; Dicyclomine; Doxylamine; Drug Com	1985

doxylamine and Pernicious Vomiting of Pregnancy