Presentation; Breech, With External Version Before Labor
Conditions
Brief summary
Moxibustion was tested for version of a breech position in singleton pregnancies. The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study.
Detailed description
Moxibustion was tested for version of a breech position in singleton pregnancies. The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study. Sample size calculation gave 45 women in each group, based on alfa 0.05 and beta 20 under condition of a 30 % effect of moxibustion vs. 20 % of spontaneous version in the control group in primiparae and 60 % in multiparae, respectively. Thus, 4 times 45 women in each group were sought. Only women who had performed three treatments were judged under the principle of intention to treat. Exclusion criteria at inclusion in week 32 was bleeding in 2nd and 3rd trimester, placenta insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, elevated blood pressure, pelvic insufficiency, low placental position, uterine malformations, former uterine corrective surgery and known fetal morbidity
Interventions
OTHERMoxibustion in primiparae
Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
OTHERMoxibustion in multiparae
Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Sponsors
Herning Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pregnant women with singleton breech position of their babies
Exclusion criteria
* vaginal bleeding in 2nd and 3rd trimester, placental insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, high blood pressure, pelvic insufficiency, low placental position, placenta praevia, uterine malformations, previous corrective uterine surgery, known fetal morbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment | 4 weeks | Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moxibustion in Primiparae Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae
Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae | 48 |
| Moxibustion in Multiparae Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae
Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae | 54 |
| Control Primiparae No intervention. Routine control schedule for primiparae with midwife | 44 |
| Control Multiparae No intervention. Routine control schedule for multiparae with midwife | 54 |
| Total | 200 |
Baseline characteristics
| Characteristic | Control Multiparae | Total | Moxibustion in Multiparae | Control Primiparae | Moxibustion in Primiparae |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 200 Participants | 54 Participants | 44 Participants | 48 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 3 | 30 years STANDARD_DEVIATION 4 | 31 years STANDARD_DEVIATION 3 | 29 years STANDARD_DEVIATION 4 | 28 years STANDARD_DEVIATION 4 |
| Gender Female | 54 Participants | 200 Participants | 54 Participants | 44 Participants | 48 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gestational age | 231 days STANDARD_DEVIATION 7 | 230 days STANDARD_DEVIATION 6 | 230 days STANDARD_DEVIATION 6 | 230 days STANDARD_DEVIATION 7 | 229 days STANDARD_DEVIATION 6 |
| Region of Enrollment Denmark | 54 participants | 200 participants | 54 participants | 44 participants | 48 participants |
| Weight | 74 kg STANDARD_DEVIATION 15 | 76 kg STANDARD_DEVIATION 14 | 78 kg STANDARD_DEVIATION 14 | 75 kg STANDARD_DEVIATION 12 | 76 kg STANDARD_DEVIATION 14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 54 | 0 / 44 | 0 / 54 |
| serious Total, serious adverse events | 0 / 48 | 0 / 54 | 0 / 44 | 0 / 54 |
Outcome results
Primary
Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment
Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxibustion in Primiparae | Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment | 34 participants |
| Moxibustion in Multiparae | Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment | 25 participants |
| Control Primiparae | Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment | 34 participants |
| Control Multiparae | Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment | 25 participants |
p-value: 0.4895% CI: [0.77, 1.76]Chi-squared
p-value: 195% CI: [0.69, 1.46]Chi-squared