Status:
COMPLETED
Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy
Lead Sponsor:
Xiaoke Wu
Collaborating Sponsors:
Ningxia Hui Autonomous Region Hospital of TCM
Jiangxi Maternal and Child Health Hospital
Conditions:
Nausea and Vomiting of Pregnancy
Eligibility:
FEMALE
20-45 years
Phase:
PHASE3
Brief Summary
Nausea and vomiting in pregnancy (NVP) is one of the most common symptoms of pregnancy affecting 50-85% of women during the first half of pregnancy. Maternal morbidity is common and includes psycholog...
Detailed Description
Subjects will be randomized into one of the four treatment arms: A) active acupuncture (30 min /every day) + Diclectin (combination of doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg)...
Eligibility Criteria
Inclusion
- Women with 20-45 years of age;
- PUQE score ≥6;
- 7-14 weeks of gestation with viable fetus inside the uterine cavity confirmed by ultrasound dating;
- Less than 20% weight loss.
Exclusion
- Having major medical problems such as malignant tumor, acute or subacute severe hepatitis, severe aplastic anemia, idiopathic thrombocytopenic purpura, acute appendicitis, acute pancreatitis, TORCH syndrome, etc
- Having chronic medical conditions such as poorly controlled diabetes, coronary heart disease, uncontrolled hypertension, etc
- Coexistence of other diseases that cause vomiting such as infectious disease, gestational trophoblastic disease, etc
- Having asthma, increased intraocular pressure, narrow-angle glaucoma, narrow peptic ulcer, pyloric obstruction, bladder neck obstruction, etc
- Taking antiemetics such as vitamin B6, ondansetron, metoclopramide, prednisone, anti-vomiting Chinese medicine, etc., within the past week
- Receiving conservative treatment such as dietary and lifestyle modification
- Abnormal physical examination and laboratory tests (minor abnormalities in laboratory tests due to pregnancy vomiting, such as liver function and ions, are acceptable for inclusion)
- Having mental handicaps or psychological disorders
- Allergic to doxylamine, other ethanolamine-derived antihistamines, pyridoxine hydrochloride, or any inactive ingredient in diclectin
- Using monoamine oxidase inhibitors
- Driving or operating heavy machinery
- Using alcohol or other central nervous system inhibitors
Key Trial Info
Start Date :
June 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT04401384
Start Date
June 21 2020
End Date
January 31 2022
Last Update
April 4 2022
Active Locations (13)
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1
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Harbin, Heilongjiang, China
2
Heilongjiang provincial hospital
Harbin, Heilongjiang, China
3
Hegang Maternal and Child Health Hospital
Hegang, Heilongjiang, China
4
Affiliated Hospital of Jiamusi Medical University
Jiamusi, Heilongjiang, China